The Pharma World

INTERVIEW

During Covid-19, Dhaka Medical College
Hospital is providing an excellent
service to our patients

Prof. Dr. A.F. Mohiuddin Khan As an eminent ENT specialist of anosmia, sore throat, loss of taste
Ex. Head of the Dept. of ENT the country, would you please sensation, headache etc.
Dhaka Medical College & Hospital tell us about the common ENT
disease prevalent in Bangladesh? How are facilities available in
Bangladesh for management
Common ENT diseases include Ad- of ENT diseases?
enotosillitis, pharyngitis, common
cold, Upper RTI, Otitis media with Facilities available in Bangladesh for
effusion, wax, otomycosis, epistaxis, management of ENT disease are ade-
foreign body in nose, throat and ear in quate. As for example, in this Covid-19
case of children. And Chonic suppura- pandemic situation, there are few
tive otitis media, Otitis externa, Pres- Covid specialized hospitals including
byacusis, Allergic rhinitis, Obstructive Dhaka medical college hospital which
sleep apnoea, Globus pharyngeus, is giving a milestone service for the
Chronic pharyngitis are common in nation. Some non-government hospi-
adult population. tals are also providing good service to
the Covid-19 patients.
What are the common ENT
diseases people face in winter? Compared to advanced
countries, where do we stand in
In winter Adenotonsillitis, common treatment of ENT diseases?
cold, Allergic rhinitis are most com-
mon diseases. Sore throats are com- We stand in a better position com-
mon in winter and and it is usually pared to other advanced countries.
caused by viral infections. Doctors in our country are giving an
excellent service to the patients.
Is there any preventive
measure to get rid of this? Do we have sufficient
skilled ENT specialist in the
There is evidence that wearing warm country? Is it adequate?
cloths, avoiding cold water intake,
gurgling with slight warm water can We have sufficient and adequate ENT
reduce the sore throat. One can also specialists in our country. But our
prevent colds by washing your hands doctors need more training abroad to
regularly. This destroys bugs that you enrich their knowledge and expertise.
pick up from touching surfaces used
by other people. It is also important Do you think that the quality
to keep the household items such as of the drugs produced by our
cloths, bedsheet, towels clean. Prac- local pharma companiesare
tice good hygiene, such as covering good enough for ENT disease?
your mouth when you cough and
staying at home. The quality of the drugs produced by
our pharmaceuticals companies are
Is there any ENT diseases good enough for ENT diseases. Some
related to covid-19? pharmaceuticals companies are also
exporting their products to many for-
ENT disease related to Covid 19 are eign countries. l

THE PHARMA WORLD 51

RESEARCH UPDATE

Antibiotics may be best first possibility, saying there’s no evidence unexpected, but positive, side effect:
treatment for appendicitis it happens. The new proof comes New research suggests that people
from a 33-year-old man in Hong Kong taking the drug appear to have sig-
For some patients suffering from ap- who first caught COVID-19 in March. nificantly slower declines in think-
pendicitis, antibiotics may do the He was tested for the coronavirus af- ing and memory as they age. “Our
trick, a large US trial suggests. More ter he developed a cough, sore throat, six-year study of older Australians
than 70% of patients who received fever, and a headache for 3 days. He with type 2 diabetes has uncovered
antibiotics avoided surgery for at stayed in the hospital until he twice a link between metformin use and
least 90 days, according to the new tested negative for the virus in mid- slower cognitive [mental] decline
report. April. On Aug. 15, he man returned to and lower dementia rates,” said
Hong Kong from a recent trip to Spain study author. “The findings provide
Common heartburn meds and the U.K., areas that have recently new hope for a means of reducing
tied to higher diabetes risk seen a resurgence of COVID-19 cases. the risk of dementia in individuals
At the airport, he was screened for with type 2 diabetes, and potentially
Often-used drugs called proton COVID-19 using a test that checks those without diabetes,” Research-
pump inhibitors (PPIs) ease heart- saliva for the virus. He tested positive, ers said.
burn symptoms, but a new study but this time, had no symptoms. He
suggests they might also increase was taken to the hospital for monitor- Could Zinc help fight COVID-19?
the risk of type 2 diabetes. Chinese ing. His viral load -- the amount of
researchers drew on information virus he had in his body -- went down Millions of people pop zinc supple-
from studies of more than 200,000 over time, suggesting that his im- ments at the first sign of the common
US health care professionals and mune system was taking care of the cold. Now, new research suggests the
found that regular use of PPIs was intrusion on its own. nutrient might play a role in COV-
associated with a 24% higher risk of ID-19 outcomes, too. Researchers from
developing type 2 diabetes. The re- Multiple studies confirm Spain reporting at a European corona-
searchers also found that the longer steroids can fight virus conference found that hospital-
people used the drugs, the higher severe COVID-19 ized COVID-19 patients with low blood
their odds of diabetes. “Regular PPI levels of zinc tended to fare worse
use was likely to be associated with A slew of “gold standard” clinical than those with healthier levels.
an increased risk of type 2 diabetes, trials offer new hope for patients
particularly for those with prolonged battling severe COVID-19: cheap, Could long Naps
use,” the authors said. common drugs known as corticoster- shorten your life?
oids appear to cut the death rate by
Study confirms it’s possible a third. Publication of new data on A frequent need to nap could be a
to catch Covid twice treatment with corticosteroids such red flag for future heart problems
as hydrocortisone or dexametha- and a higher risk of early death, a
Researchers in Hong Kong say they’ve sone “represents an important step new analysis concludes. Long naps
confirmed that a person can be forward in the treatment of patients lasting more than an hour are as-
infected with COVID-19 twice. There with COVID-19,” said the researchers. sociated with a 34% elevated risk of
have been sporadic accounts on heart disease and a 30% greater risk
social media sites of people who say Diabetes drug metformin may of death, according to the combined
they’ve gotten COVID twice. But scien- protect the aging brain results of 20 previous studies.
tists have been skeptical about that
A common type 2 diabetes drug
called metformin may have an

52 THE PHARMA WORLD

RESEARCH UPDATE

Low Vitamin D levels tied to Potential COVID-19 drug Steroids cut COVID-19
higher odds for severe COVID Azithromycin may increase death rates, but not
risk for cardiac events for everyone
Low blood levels of vitamin D might
heighten people’s odds for severe Debates over whether hydroxychloro- New studies show that treating
or even fatal COVID-19, new research quine should be taken to help lessen critically ill COVID-19 patients with
shows. Taking in a healthy level of the duration and impact of COVID-19 inexpensive steroids can cut their
vitamin D may therefore “reduce the have revolved around the drug’s risk of dying from the illness by a
complications, including the cytokine reputation for causing cardiac events third. The results are so clear that
storm [release of too many proteins such as abnormal heart rhythms or the World Health Organization
into the blood too quickly] and beats and cardiac arrest. Because of changed its advice and now strongly
ultimately death from COVID-19,” said this, the US Food and Drug Adminis- recommends corticosteroids as a
study author. tration has revoked emergency use first-line treatment for the sickest
authorization for the drug in treating patients. Steroids aren’t risk-free,
Coffee may slow spread COVID-19. Another drug, azithromy- however. They can have side effects,
of Colon Cancer cin—a commonly-prescribed anti- and they could do more harm
biotic—also is being investigated as than good in patients with milder
Just a few cups of coffee a day may a potential treatment for COVID-19. cases of COVID-19. It’s important
help slow down the deadly progres- Azithromycin’s association with car- to understand that steroids
sion of advanced colon cancer, new diac events also has been debated. can benefit the sickest patients
research finds. Of the nearly 1,200 pa- In 2012, the FDA issued a warning for hospitalized with COVID-19, but
tients in the study, those who drank azithromycin stating that it had been they’re not a treatment for relatively
four or more cups of java on a daily linked to cardiac events, but subse- mild cases.
basis had 36% higher odds of surviv- quent studies have yielded mixed
ing during the 13-year study period. results. Now, researchers from the Antibiotics might
Metastatic colon cancer, which has University of Illinois Chicago have lower effectiveness of
spread from its original location, “re- found that azithromycin by itself is Birth Control Pill
mains an incurable disease in most not associated with an increase in
cases,” says the study. cardiac events; however, if the drug Doctors have long suspected it,
is taken with certain other drugs but a comprehensive new study
Proton-pump inhibitors that affect the electrical function- provides more evidence that anti-
may reduce benefits ing of the heart, then cardiac events biotics can reduce the effectiveness
of atezolizumab in increased. of birth control pills. That means
urothelial carcinoma women who are using both types
Novel coronavirus may of drugs at once should take extra
The use of proton-pump inhibi- have been circulating precautions to avoid an unintended
tors (PPIs) is associated with worse in bats for decades pregnancy, the study’s British au-
overall survival in patients with thors say.
urothelial carcinoma treated with the A team of researchers assessed the
immune-checkpoint inhibitor (ICI) at- evolution of the novel coronavirus,
ezolizumab, but not in those treated SARS-C0V-2, and found that the
with chemotherapy, according to a lineage of the virus may have been
retrospective study. circulating undetected in bats for
decades. Using phylogenetic dating
methods to determine ancestral
relationships of viral lineages,
researchers found that SARS-CoV-2
aligns closely with bat viruses,
which may have mutated into the
novel coronavirus approximately 40
to 70 years ago.

THE PHARMA WORLD 53

ARTICLE

Global Status of Biosimilars
and its Influential Factors

DR. MD. ABU ZAFOR SADEK is serv- n Dr. Md. Abu Zafor Sadek by biological products [1]. In last five
ing as Marketing Manager at UniMed years huge number of biological prod-
UniHealth Pharmaceuticals, a leading Abstract – The history of biosimilars ucts have approved all over the world
pharmaceutical company of Bangla- started at European Union (EU) in 2006 and almost 600 products are in pipeline
desh having business connection with with one product; however, currently [2]. Usually biological products are ex-
Johnson & Johnson (J&J), Abbott and it has been recognized everywhere in pensive than that of chemical products
other globally reputed companies. the world and EU have highest 64 bio- that leads to huge increment of total
similar products. United States Food treatment cost [3]. Apart from the above
Prior to this, he worked as Senior & Drug Administration (USFDA) was many biotech products are going to off
Additional Manager at Renata Lim- little unadventurous with biosimilars; patented soon. Also, health spending
ited. He also worked as Short-Term nevertheless, they approved the first as a percentage of GDP (Gross Domestic
Consultant of The World Bank, Dhaka, biosimilar 09 years after EU approval Products) is decreasing or almost static
Bangladesh. and presently they have 28 biosimi- in many developed countries like Unit-
lars which are playing significant role ed Kingdom (UK), Spain, Italy etc. and
Graduating in Pharmacy from Khul- in price cutting of branded biologics. increasing in several emerging coun-
na University, Dr. Zafor started his ca- They also have so many biosimilars in tries like India, China, Russia, South Af-
reer as Product Executive. Thereafter, product pipeline. Economically emerg- rica, Brazil, Turkey etc. [4].
he completed his MBA in International ing countries especially China & India
Business from the Faculty of Business are very aggressive with biosimilars. Some developed countries have not
Studies, University of Dhaka & Doctor been able to solve the problem of the
of Business Administration from (DBA) In view of easy regulation, cheap increase costs of health care result-
from Institute of Business Administra- labor & other cost related factors ing from technological development,
tion (IBA) of the same University. they are in little advantageous than public expectations and particularly
the rivalries. Under Pharmaceutical the rapidly increasing size of their el-
He has more than 15 years career Benefits Scheme Australian govern- derly populations. Also, the people of
in pharmaceutical marketing, manage- ment is encouraging biosimilars and various developing countries are still
ment and training with excellent track they already approved 20 biosimilars. living in below poverty line with dys-
record. His area of interests includes Japan, Korea, Canada, South Africa are functional health care systems and ex-
launching time demanded new prod- also promoting biosimilars. tremely limited access to basic medi-
ucts, brand management, strategy for- cal care [5].
mulation, business opportunity identifi- However, it is worth mentioning
cation, international business, training, that in spite of enormous potenti- The biosimilars market is up-ward-
negotiation, conducting CME etc. ality and rapid growth till to date ing exponentially with the industry
biosimilar market is insignificant com- forecast to be worth $25 billion by
He has 5 publications in different pared to total pharmaceutical market 2020 [6]. Hence, biosimilars are equally
local & international journals includ- and success of biosimilars will de- important for both developed & de-
ing International Journal of Business pend on the acceptance by the physi- veloping countries. Considering the
& Management, Canada and Journal cians, treatment cost reduction, trust above this study find out the present
of Business and Economics, USA. on manufacturer, proper information, status of biosimilars across the world
drug substitution, efficacy, safety etc. and some influential factors associ-
He has presented biosimilars and ated with its growth.
other topics at different conferences Index Terms – Biosimilars, follow on
in Spain, Singapore and USA. biologics, branded biologic, USFDA, II. Objectives
price-cut, regulation, rapid growth,
acceptance, potential, substitution, The objective of this study is to pre-
treatment cost, drug substitution, ef- sent the current approval status and
ficacy and safety. market potential of different biosimi-
lars across the world including major
I. Introduction pharmaceutical markets. Also, the
study aims to narrate the major factors
By 2020 almost 28% of the worldwide associated with the growth of biosimi-
pharmaceutical market will be shared lar products.

54 THE PHARMA WORLD

ARTICLE

III. Methodology 5) follicle-stimulating hormone (FSH); the global market [12, 14]. As of now
6) parathyroid hormone; the number of approved biosimilars
This is a qualitative and exploratory 7) tumor necrosis factor (TNF)-inhibi- by USFDA is 28 where the most recent
study. All the data are collected from one is Hulio (adalimumab) [15].
secondary sources and the author tor; and
mostly relied on different journals, 8) monoclonal antibodies (MABs) [10]. However, it is assessed that bio-
reference books, articles and various similars will lead to a $44.2 billion re-
reputed websites. All the information B. Biosimilars in USA duction in spending on biologic drugs
gathered were precisely referenced The USFDA was authorized to approve from 2014 to 2024, or about 4% of total
and compiled with the concern of biosimilars by the BPCI (The Biologics biologic spending over the same pe-
providing a detailed understanding of Price Competition and Innovation) Act riod, with a range of $13 billion to $66
biosimilars status. passed by the US Congress on March billion [16].
23, 2010 and has issued a draft guid-
IV. Findings ance in early 2012 [11]. C. Biosimilars in Emerging Countries
China, India, Brazil and Russia, among
A. Biosimilars in Europe The biosimilars market in the Unit- others, already have top in the market-
In the European Union (EU), a legal ed States (US) has got momentum place, but they are about to dive in and
structure for approving biosimilars after the introduction of Novartis’ change everything. Each of the said
was established in 2003. This edifice Zarxio (Filgrastim-sndz) in September markets is huge. Under current cir-
reveals that biosimilars can only be 2015. Zarxio, the first biosimilar to be cumstances, parochial clinical trial re-
approved centrally via the European approved in the US, was a notewor- quirements and an uneven regulatory
Medicines Agency (EMA) and it will not thy development resulting in auspi- playing field would force many outside
be wise to approve nationally. EMA cious emerging trends for the growth companies to establish distinct divi-
first developed guidelines for the ap- of global biosimilars market. Sandoz sions simply to develop biosimilars in
proval of biosimilars via an abbrevi- claims that the launch of biosimilar China and many other countries. The
ated registration process during 2005 has led to the gradual attrition of the future success of biosimilars is not de-
to 2006 and since then EMA has de- market share of Amgen’s Neupogen; pendent on the US and Europe alone.
veloped many universal and precise as Amgen’s first quarter 2016 results The need is greatest in Asia and this
guidelines for biosimilars [7]. Neupogen (filgrastim) sales decreased market will influence the worldwide
by 13% driven by the effect of intense condition and be the fastest to adopt
By January 2016, 19 biosimilars market competition in the US [12]. biosimilars. Drivers for fast uptake in-
based on 08 originator products-in- clude low clinical development cost,
cluding the world’s first monoclonal The main three factors that sug- unconstrained product launches due
antibody biosimilar had been ap- gests biosimilars penetration may to a different patent landscape, cheap
proved for use in Europe. In 2013, bio- eventually reach high level in the US workforce, less strict regulatory frame-
similars were responsible for around market are the price of pharmaceutical work and therapy primarily chosen
a quarter of all sales of biologics for (double compare to average price of by physicians [17]. Biosimilars have
which EU patents had expired. The Eu- the rest of the world), total amount of progressively added traction over the
ropean involvement with biosimilars healthcare expenditure (18% of GDP) past few years. Forecasts suggest that
has exposed substantial cost savings and new health legislation-2014 [13]. global sales could more than double
for healthcare providers and patients, to $15 billion by the 2020s, with an es-
with no reports of untoward effects or As the US region would contribute timated $5 billion to $8 billion coming
unexpected adverse events with bio- single-digit revenue share in overall from emerging markets [18].
similars in Europe till to date [8]. biosimilar market by 2020. Recently
the USFDA (United States Food and D. Biosimilars in India
Some studies estimate that by Drug Administration) has approved India, with its well-known track record
2020, overall savings in the European its second biosimilar product Inflectra of evolution in the generic pharmaceu-
Union could range from $16 to $45.2 (infliximab-dyyb) as a reproduction of tical industry, can potentially emerge
billion [9]. Janssen Biotech’s drug Remicade (inf- as a strong international player in the
liximab). Though, Inflectra (infliximab) biosimilar segment. The Indian bio-
Till to date, EMA has endorsed the has already approved to market in similar industry is anticipated to grow
sanction of 64 biosimilars within the many countries such as Canada, Mex- from $4 billion in 2015 to more than
product classes of: ico, Australia and European regions, it $70 billion by 2025. Currently, more
1) growth hormone (GH); is the first biosimilar monoclonal an- than 50 biotherapeutics are approved
2) granulocyte colony-stimulating tibody (MABs) to be approved in the in the country and more than half are
US. Such developments would expose
factor (GCSF); new opportunities for pharmaceuti-
3) erythropoiesis stimulating agent cal companies and drug developers in

(ESA);
4) insulin;

THE PHARMA WORLD 55

ARTICLE

biosimilars. Although India does not have been approved in South Korea er than what currently exists along
have strict regulations, it has a big since 2012 and currently this num- with the highest quality and safety
potential for biosimilars. Most innova- ber is 12 [23]. Currently the number profiles of their biosimilars [1].
tor biotherapeutics are unaffordable South Korea is pointing to capture a
to the average patient in India, even big share of the $110bln of value that Indian Drug firm Cipla will invest
though the price in the local market Citigroup expects to flow from innova- around Rand 1.3 billion (over Rs 590
is usually lower than that in Western tor companies to biosimilars over the crore) to launch a manufacturing facil-
countries [19]. Till to date around 90 bi- next decade. Biosimilars have higher ity in South Africa for the production of
osimilar products have been approved barriers to entry than traditional ge- biosimilars. The company’s “proposed
in India and, according to Generics and nerics because of the huge invest- biotech subsidiary in South Africa will
Biosimilars (GaBI’s) list [20]. ment and risk involvement. Yet Cell- invest just over R 1.3 billion into the
trion, a promising name among bio country’s first state-of-the-art biotech
E. Biosimilars in China overcame these hurdles to develop manufacturing facility, for the produc-
Available data shows 40% of China’s the first copy of Johnson & Johnson’s tion of biosimilars” [26]. South Africa’s
$1.5bln recombinant biologic prod- rheumatoid arthritis drug Remicade, Medicines Control Council (MCC) has
uct sales come from similar biologics, the world’s third best-selling drug last approved the country’s first non-orig-
which have enjoyed approximately year with sales of $10bln.This was seen inator biological, filgrastim, from Teva
25%-30% Compound annual growth as a milestone not only because of its Pharmaceutical Industries [27].
rate (CAGR) over the past decade. If high value but also because it was the
the market remains to grow at 25% per first of a more complex group of bio- H. Biosimilars in Japan
year, the similar biologic market could logics called monoclonal antibodies Pharmaceutical market of Japan is
grow to $2bln, around 20% of the global (MABs) to face biosimilar competition. the second most important market
biosimilar market by 2015. There are in the world after the United States
numerous issues driving the domestic The Celltrion version, known as with a sale of over $143 billion in 2014,
biosimilar market: Firstly, changes in Remsima or Inflectra, was launched in representing 14% of the global phar-
disease pattern; shifting of infectious Europe in February and is now sold in maceutical market. The biopharma-
diseases to non-communicable dis- 40 countries across the globe. But the ceutical market in Japan is of great
eases (NCDs). Secondly, significant price biggest market by far-the USA-so far import to the world. However, most of
reductions compared to originator remains elusive. The USFDA (United the products sold there are of foreign
products encourage reimbursements. States Food and Drug Administration) origin but manufactured locally under
Thirdly, a window of opportunity has approved its first biosimilar earlier this license [28].
been involuntarily created by today’s year in a sign that America is finally
biosimilar leaders. As the first wave of opening to the category after years of In March 2009, guidelines for bio-
biologic originators did not file or ade- lobbying against it from some big phar- similars, based on the European Un-
quately protect its IP (Intellectual Prop- maceuticals and biotech groups [24]. ion’s existing processes, were issued
erty) in China during the 1990s, a num- To date, the Ministry of Food and Drug by the MHLW (Ministry of Health, La-
ber of local companies took benefit of Safety (MFDS) has approved 11 biosimi- bour and Welfare). These guidelines
this window of opening [21]. In February lars within the product classes of HER2- deliberate biosimilar drugs to be
2019, National Drug Regulators in China inhibitor, insulin, tumour necrosis fac- those products that are equivalent
approved the first ever biosimilar prod- tor (TNF)-inhibitor and monoclonal and homogenous to the reference bi-
uct referencing Rituxan, a monoclo- antibody, for use in South Korea [25]. ological product in terms of efficacy,
nal antibody. This biosimilar product, quality and safety [28].
HLX01 (Hanlikang), was developed by G. Biosimilars in South Africa
Shanghai Henlius Biopharmaceutical South African medicine market is The first biosimilar to take ap-
(Henlius), and is indicated in the treat- very sophisticated. Generics make up proval in Japan was Sandoz’s growth
ment of non-Hodgkin’s lymphoma. This more than 50% of the market. Bio- hormone treatment Somatropin BS
approval signaled the beginning of the similars guidelines were released in (somatropin) in June 2009. Till to date,
Biosimilar boom in China [22]. 2010. There is a financial burden on the PMDA (Pharmaceuticals and Medi-
the system overall and great pressure cal Devices Agency) has permitted
F. Biosimilars in Korea to utilize generics including biosimi- seven biosimilars within the product
According to the Korea Pharmaceuti- lars. There is a cost containment focus classes of human growth hormone
cal Manufacturers Association (KPMA), from the government and payer side (HGH), granulocyte colony-stimulating
the biosimilars market in South Korea and a quality focus from the physician factor (GCSF), erythtropoesis stimu-
grew to $130 million, nearly twice in and patient side. Companies will have lating agent (ESA), insulin and tumour
size from its 2013 value. Six biosimilars to bring in a cost structure that is low- necrosis factor (TNF)-inhibitor, for use
in Japan [28]. The PMDA has approved
21 biosimilars, within the product

56 THE PHARMA WORLD

ARTICLE

classes of human growth hormone, ance on how to gratify the data and L. Issues Influencing the Emerge of
granulocyte colony-stimulating fac- regulatory requirements under the Global Biosimilars Market
tor, erythropoiesis stimulating agent, Food and Drugs Act and Regulations The ongoing sharp rise in healthcare
insulin, angiogenesis inhibitor and for the authorization of subsequent expenditure is untenable and impos-
tumour necrosis factor [29]. entry biologics (SEBs) in Canada [11]. es a substantial financial burden on
patients, potentially limiting access
I. Biosimilars in Australia The first biosimilar in Canada, Om- to many effective therapies. In view of
The Australian Government recog- nitrope (somatropine), was approved that above and rise in health budget
nized the emerging role of biosimilar in 2009 and Health Canada endorsed in emerging countries biosimilars are
medicines and will play in providing Celltrion’s Remsima/Inflectra in 2014. gaining huge attention [36]. More than
treatment opportunities to Austral- Health Canada recently issued re- hundred biosimilars have been ap-
ians in upcoming years. They have structured draft subsequent entry proved globally. Almost 15 patented
launched an initiative aimed at im- biologics (SEB) guidance, which will biologics will be expiring by the end
proving awareness and confidence in likely be finalized in 2016. There are of 2020; also, it is foreseeable that the
biosimilar medicines amongst pre- now multiple pending patent cases global biosimilars market could reach
scribers, pharmacists and patients in involving biosimilar products on the $25-$35 billion by 2020 representing a
Australia. It has allocated $20 million Federal Court of Canada’s docket, with CAGR of 62.1% [37].
to this initiative over a three-year pe- many novel issues at stake. Canada’s
riod [30]. In accordance with this ap- provinces are finally figuring out how The followings are the influential
proach, the Therapeutic Goods Admin- to capitalize on biosimilar compe- factors for the growth of the biosimilars.
istration (TGA) released its updated tition within their formularies [33]. a) Acceptance of biologic drugs
guidelines on biosimilars, specifically Thus far in 2020, Health Canada has
referring to a number of European approved seven biosimilars of six in- is growing mostly for chronic
Medicines Agency (EMA) guidelines novator products. This brings the to- diseases (diabetes, arthritism and
providing standards for quality, non- tal Health Canada approvals to 25 bio- heart diseases) which are difficult
clinical and clinical data requirements similars of 12 innovator products [34]. to treat with small-molecule drugs
for biosimilarity. In particular, the b) Customers & pharmacy benefit
pricing consequences of the listing K. Scope for biosimilars due to patent managers are continuing to
of a biosimilar medicine on the PBS expiry progress their coverage strategies
(Pharmaceutical Benefit Scheme) are Table I: List of Biologics going to be c) Finalizing the Biosimilars
now certain a 16% price drop (from the off patented soon interchangeability guidelines by
subsidized price the government pays USFDA.
the sponsor) will happen on reference
brands following the first listing of a Sl Brand Biologic Indication Market
biosimilar medicine on the PBS. The 1 Humira Adalimumab Rheumatoid Arthritis 10.8
PBS listing of Inflectra brings a total of 2 Lantus Insulin Glargine Diabetes 9.2
09 biosimilar medicines approved for 3 Rituxan Rituximab Rheumatoid Arthritis 8.6
use in Australia [31]. However, till to 4 Enbrel Etanercept Rheumatoid Arthritis 8.3
date, TGA has permitted 20 biosimilars 5 Remicade Infliximab Crohn’s Disease 7.9
within the therapeutic classes of hu- 6 Avastin Bevacizumab Ovarian Cancer 7
man growth hormone (HGH), granulo- 7 Herceptin Trastuzumab Breast Cancer 6.8
cyte colony-stimulating factor (GCSF), 8 Avonex Interferon Beta-1A Multiple Sclerosis 5.5
insulin, erythropoietin, follicle stimu- 9 Copaxone Glatiramer Acetate Multiple Sclerosis 4.6
lating hormone (FSH), monoclonal 10 Neulasta Pegfilgrastim Neutropenia 4.5
antibody (MABs) and tumour necrosis 11 Lucentis Ranibizumab Macular Degeneration 4.5
factor (TNF)-inhibitor, for use in Aus- 12 Levemir Insulin Detemir Diabetes 2.5
tralia [32]. 13 NovoMix 30 Insulin Aspart Diabetes 1.8
14 Xolair Omalizumab Allergic Asthma 0.8
J. Biosimilars in Canada 15 Erbitux Cetuximab Colorectal Cancer 0.25
In 2010, Health Canada delivered the 83.05
“Guidance for Sponsors: Information Total
and Submission Requirements for
Subsequent Entry Biologics (SEBs)”,
whose objective was to provide guid-

THE PHARMA WORLD 57

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d) Opportunity for biosimilars to both rich and poor across the world. Biotechnology in Pharmaceuticals-Bang-
be available at all distribution Also, patent expiry of some high val- ladesh Perspective” The Pharma World,
channels including full-line, ued biotech products and regulatory Dhaka, Bangladesh, March.
wholesale distribution [38]. relaxation are pushing the rise of bio-
similars. Europe, USA, Japan, Canada [3] Erwin A. Blackstone and Joseph P. Fuhr,
e) Numerous blockbuster biologics- and Australia are the top places for Jr. (2012). Innovation and Competition:
Humira, Remicade and Lantus are pharmaceutical market and they very Will Biosimilars Succeed? Biotechnol-
going to lose patent protection rich with biologic products. Their re- ogy Healthcare, USA. Spring; 9(1): 24–27
over the next five to 10 years. It is cent inclined towards biosimilars (Available from https://www.ncbi.nlm.
worth mentioning that they are has offered a paradigm shift in the nih.gov/pmc/articles/ PMC3351893/).
high valued and mostly prescribed booming of biosimilars. Therefore, it
biologics globally. is estimated that biosimilar market [4] The World Bank Databank (2015). (Avail-
will enjoy an exponential growth in able from http://data.worldbank.org/).
f) Specialist doctors, patients at the the upcoming years which will be far
middle of biosimilars potential higher than chemical pharmaceutical [5] Ralf Otto, Alberto Santagostino and Ulf
as prescription & usage rates are products. Although some developed Schrader (2014). Rapid growth in biop-
linked to Return on Investment & developing countries have finalized harma: Challenges and opportunities,
models their biosimilar guidelines but many McKinsey & Company, USA. December.
others are yet to publish it and there (Available from http://www.mckinsey.
g) Lucrative price advantages is some discrepancy among the pub- com/ industries/pharmaceuticals-and-
influence the governments in lished guidelines. Beyond doubt bio- medical-products/our-insights/rapid-
different countries to incentivize similars are growing fast but accept- growth-in-biopharma.
to use biosimilars ance by the physician, legal issues,
technological soundness, reduction of [6] SMi (2016). SMi Group’s 7th Annual
h) Clatter of global giants making in total treatment cost, legal harmoniza- Biosimilars Europe Conference, London,
Europe and emerging markets tion etc. need to be considered for the UK. 29th September to 30th September
upcoming days of biosimilars. l (Available from https://www.smi- online.
i) Drug delivery device firms knock co.uk/pharmaceuticals/uk/biosimilars-
the sweet spot Acknowledgement europe).
The author would like to acknowledge
j) The healthcare industry is all the individual writers, researchers, [7] GaBi (2014). EU guidelines for Gener-
becoming biased to urban areas authorities and organizations from ics and Biosimilars Initiative (GaBi),
[39]. where information was gathered to Belgium. biosimilars (www.gabionline.
accomplish this paper. The author is net). Mol, Belgium: Pro Pharma Commu-
k) Advanced prevalence of cancer also grateful to Dr. Syed Ferhat Anwar, nications International. July. Available
and existence of stringent Professor & Director, Institute of Busi- from: www. gabionline.net/Guidelines/
regulatory have enabled North ness Administration (IBA), University EU-guidelines-for-biosimilars.
America & Europe to emerge of Dhaka for his kind guidance and
dominant in the global Oncology support. It would be incomplete if [8] Quintiles IMS (2016). Intercontinental
biosimilars market the author does not mention the con- Marketing Services, Health, USA. Avail-
tribution of his family members and able from http://www.quintiles.com/
l) Asia-Pacific is scheduled to currently working company to write microsites/biosimilars-knowledge-
emerge as a strong regional this article. connect/biosimilars-by-region/europe.
market, mainly owing to the
growing populations and References [9] Tina Valbh, BS Pharm, RPh (2016).
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rope.

[11] Jun Wang and Shein-Chung Chow (2012).
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Biosimilar Products, Pharmaceuticals

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ARTICLE

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risks-opportunities-biosimilars). the European Journal of Business
and Management Research]

THE PHARMA WORLD 59



IN DEPTH

Unexpected benefits of a well-known wonder drug

Although it used to be known as “the wonder drug those at high risk of preeclampsia but without such
that works wonders,” we now know that aspirin history remains to be elucidated. High-risk patients
can be a very dangerous drug largely because it could be given this treatment during the first trimester
increases the risk of internal bleeding—especially in of pregnancy, but screening procedures need to be re-
older adults who drink alcohol, those with a history of searched, the authors noted.
ulcers, or those taking anticoagulants. In such popula-
tions, the risk of taking aspirin likely outweighs the ben- Aspirin efficacy for preeclampsia prevention is dose-
efits. Bleeding risk even occurs in those taking low-dose dependent, with an optimum dosage—between 75 mg/day
81-mg formulations (ie, baby aspirin), not just from the and 150 mg/day—to be determined.
regular strength dose of 325 m.
As for a mechanism, the authors suggested that in
In people who are at lower risk for bleeds, though, as- preeclampsia, “platelet TXA2 increases significantly,
pirin may provide many benefits that could outweigh the whereas prostacyclin drops sharply. This imbalance is
drawbacks, per the experts. These benefits extend well present from 13 weeks of gestation in patients at high
past the commonly known benefits of pain relief and risk. TXA2/PGI2 imbalance can be reversed by 2 weeks
stroke prevention. Here are five of aspirin’s unexpected of treatment with low-dose aspirin, which inhibits TXA2
benefits—for neurocognition, pregnancy, and cancer. secretion, and thus platelet aggregation, without alter-
ing secretion of endothelial prostacyclin (PGI2), thereby
Dementia prevention in some favoring systemic vasodilatation.”

Preclinical studies have indicated that nonsteroidal anti- Lung cancer
inflammatory drugs (NSAIDs) could prevent the onset of
Alzheimer disease, a hypothesis that’s been supported Low-dose aspirin use for the chemoprevention of lung
by various observational studies conducted since the cancer is a hot topic. Certain randomized trials have
1990s.  demonstrated beneficial effects of long-term, low-dose
aspirin use, although population-based studies—par-
Based on the results of a  meta-analysis  of cross- ticularly among women—have failed to support this as-
sectional, retrospective, or prospective observational sociation.
studies, the researchers found that NSAID exposure de-
creased risk of Alzheimer disease. Drawing from 11 stud- Results from a recent population-based  study  iden-
ies that met inclusion criteria, the combined risk esti- tifying aspirin-use and lung-cancer data representing
mate for the development of Alzheimer disease was 0.51 12,969,400 people demonstrated that doses of ≤ 100 mg dai-
with NSAID exposure. In prospective studies, this risk was ly taken at least 2 days per week was linked to a significant
0.74, and in studies reporting a duration of aspirin use of decrease in lung cancer risk. Specifically, lung cancer risk
2 or more years, the risk was 0.42. reductions were 4%, 6%, and 11% following usage periods of
5 to 6 years, 7 to 8 years, and 9 years, respectively.
More recent large, NIH-sponsored clinical trials examin-
ing the effects of daily aspirin use in healthy adults aged 65 Colorectal cancer
years or greater provide an important caveat, though. As-
pirin use likely doesn’t help those who are healthy, without A plethora of data exist to support the use of aspirin as
a supported indication such as a history of stroke or heart a chemopreventive strategy. These data are so compel-
attack. It remains to be elucidated whether aspirin proffers ling that they support the use of this intervention as an
any protective effects if taken before the age of 65. indicated recommendation, per the authors of a review
article  published in  Best Practices & Research: Clinical
Preeclampsia prevention in some Gastroenterology.

In 1985,  evidence  emerged that low-dose aspirin taken According to the authors, “there is clear evidence that
during pregnancy could exert a protective effect against aspirin in doses as low as 325 mg per day reduces colo-
preeclampsia. Ever since that time, however, the subject rectal cancer risk. There is also strong evidence from sec-
has been controversial, despite a recent trend of taking ondary analyses of cardiovascular trials that daily doses
aspirin while pregnant. as low as 75 mg per day may be effective. In particular,
the emerging data that aspirin may reduce risk of [a]
Results from a recent review published in the jour- panoply of cancers suggest that an overall consideration
nal  Drugs  indicated that low-dose aspirin is effective of aspirin’s benefits for all cancers and vascular disease
as secondary prevention of preeclampsia in patients may dominate concerns about potential hazards at ei-
with a history of preeclampsia; however, the effect in ther dose.” l

THE PHARMA WORLD 61

RED ALERT

Ketamine: Potential risk of liver and ine was withdrawn, the reaction subsided and patient
bile duct damage gradually recovered. Levothyroxine is indicated as a
substitution therapy in hypothyroidism.
Health Canada has announced that it will work with
manufacturers to update the product safety information Flucloxacillin: Risk of renal toxicity
of ketamine-containing products (Ketalar® and generic)
to inform about the potential risk of liver and bile duct Medsafe has announced that flucloxacillin can injure the
damage. Ketamine is used to make patients unconscious kidneys as well as the liver. Both interstitial nephritis
(anesthesia) during surgery or medical procedures. and hepatitis are listed in the flucloxacillin data sheets.
Flucloxacillin is beta-lactam antibiotic and generally
Ticagrelor: Potential risk of indicated to treat infections caused by susceptible
bradyarrhythmia Gram-positive bacteria.

Health Canada has announced that it will work with Ruxolitinib, Tofacitinib: Risk of blood
manufacturers to update the product safety informa- clots in the deep veins
tion of ticagrelor to inform about the potential risk of
worsening of a slow and irregular heartbeat (bradyar- Health Canada has announced that it had worked with
rhythmia) and partial or complete block in the trans- the manufacturer for tofacitinib (Xeljanz®) to update
mission of heart impulses (second-and third-degree the product safety information to include the serious
atrioventricular block). Ticagrelor is used to decrease risk of blood clots in the veins and will also work with
the risk of having a stroke, another heart attack or dying the manufacturer for ruxolitinib (Jakavi®) to update the
from heart or blood vessel disease. product safety information to include the risk of throm-
boembolic events. Tofacitinib is used for the treatment
Tramadol: Contraindication in children of inflammatory diseases such as rheumatoid arthritis,
psoriatic arthritis and ulcerative colitis. Ruxolitinib is
Medsafe has informed health-care professionals of used for the treatment of certain rare blood cancers,
updated advice on the use of tramadol in children. such as primary myelofibrosis and polycythemia vera.
Tramadol is centrally-acting synthetic analgesic, used Health Canada conducted a safety review and found
to relieve moderate to severe pain when paracetamol that an ongoing safety study for tofacitinib showed an
or non-steroidal anti-inflammatory drug (NSAID) is not increased risk of blood clots in the lungs and death.
adequate. Tramadol is metabolized by CYP2D6 to yield
principal active metabolite. Patients with a deficiency Direct-acting oral anticoagulants
of CYP2D6 may have reduced benefit from tramadol, (DOACs): Risk of bleeding
whereas patients who are ultra-rapid metabolizers may
be more sensitive to adverse drug reactions (ADRs). The MHRA has advised health-care professionals to use
caution when prescribing direct-acting oral anticoagu-
Levothyroxine: Risk of myocardial lants (DOACs) to patients at increased risk of bleeding,
infarction such as older people or people with renal impairment.
DOACs are used for anticoagulation such as prevention
The NPRA of Malaysia has reported a case of non-ST of atherothrombotic events and of stroke and systemic
segment elevation myocardial infarction (NSTEMI) in an embolism. Available DOACs include the direct factor
80-year-old female patient after treatment with levothy- Xa inhibitors apixaban (Eliquis®), edoxaban (Lixiana®),
roxine for subclinical hypothyroidism. After levothyrox- rivaroxaban (Xarelto®) and the direct thrombin inhibitor
dabigatran (Pradaxa®).

To prevent l Wear mask when going out
Covid-19 l Maintain Social distancing
l Wash your hands frequently with soap

62 THE PHARMA WORLD

DRUG SAFETY

Bevacizumab: Risk of artery an adverse drug reaction. Memantine is indicated to
dissection control the progression of moderate to severe dementia
of the Alzheimer’s type.
The MHLW and the PMDA have announced that the
package inserts for bevacizumab (Avastin®) should be Testosterone: Caution in patients
revised to include artery dissection as an adverse drug with thrombophilia or risk factors
reaction. Bevacizumab is indicated to treat several con- for venous thromboembolism
ditions such as incurable, unresectable advanced/recur-
rent colorectal cancer and malignant glioma. The HPRA warned that testosterone-containing medici-
nal products should be used with caution in patients
Risk of acute pancreatitis with thrombophilia or risk factors for venous throm-
boembolism, following a PRAC recommendation to
The HPRA has announced that the product informa- update the product information (SmPC and PL) for these
tion (SmPC and PL) for carbimazole has been updated products. Testosterone-containing medicinal products
to reflect the risk of acute pancreatitis. Post-marketing are used as testosterone replacement therapy for male
reports of acute pancreatitis in association with the hypogonadism. Cases of venous thromboembolism have
use of carbimazole/thiamazole have been received in been reported in patients with thrombophilia, some
EU. Although the mechanism is not fully understood, of whom were on anticoagulant treatment. Continuing
decreased time to onset after re-exposure could suggest testosterone treatment in such patients requires careful
an immunological mechanism. Immediate discontinua- evaluation after a first thrombotic event.
tion is required in patients who develop pancreatitis fol-
lowing exposure to carbimazole and the patients should Aminophylline: Risk of
be switched to alternative treatment. urinary retention

Cyproterone: Restrictions in use The National Pharmaceutical Regulatory Agency (NPRA)
due to risk of meningioma of Malaysia has reported the case of urinary retention in
a 75-year-old male patient after treatment with intrave-
The HPRA of Ireland has announced that the SmPC and nous aminophylline for acute exacerbation of chronic
PL for cyproterone containing medicines will be up- obstructive pulmonary disease (COPD). Aminophylline
dated to include the risk of meningioma associated with is a combination of theophylline and ethylenediamine.
treatment. Cyproterone is an antiandrogen medicine Theophylline exerts bronchodilatory effect and is used
acting in the same way as progesterone. It is indicated for the treatment of COPD.
to treat various androgen-dependent conditions such as
hirsutism, alopecia, acne, prostate cancer and reduction Antipsychotic medicines: Risk of
of sex drive in sexual deviations in men. The Medicines cardiovascular events
and Healthcare Products Regulatory Agency (MHRA) has
announced that a European review concluded that treat- Medsafe has reminded prescribers of the risks of cardio-
ment with high dose cyproterone should be restricted vascular adverse effects from antipsychotic medicines.
to situations where alternative treatments or interven- The CARM was alerted to a case where a patient suffered
tions are unavailable, for all indications except prostate a non-fatal cardiac arrest shortly after administration of
carcinoma. an antipsychotic. Antipsychotic medicines are gener-
ally indicated to treat psychosis such as hallucinations,
Memantine: Risk of bradyarrhythmia paranoia and delusions. They may cause QT-prolon-
gation, tachycardia, arrhythmias and changes in blood
The MHLW and the PMDA have announced that the pressure. Clozapine is also associated with myocarditis
package inserts for memantine (Memary®) should be and cardiomyopathy.
revised to include bradyarrhythmia such as complete
atrioventricular block and severe sinus bradycardia as

THE PHARMA WORLD 63



CAUTION

Dangerous duos: Taking certain vitamins, minerals, or other
5 supplement supplements together can also reduce
combos to avoid absorption and may result in adverse
interactions, which can be harmful to
your health. Let’s take a look at five
supplement combos you should avoid.

Calcium and magnesium closely together to improve wound such has been mixed). What do these
elasticity and resistance. But, zinc can two supplements have in common?
Calcium and magnesium work hand- interfere with copper absorption. Fur- They both possess blood-thinning po-
in-hand to support bone health and thermore, high supplemental doses tential. Thus, taking them together can
other bodily functions. Magnesium is of zinc (≥ 50 mg/d) over the long term reduce or prevent blood clotting and
needed for calcium absorption. Be- can cause copper deficiency. Although potentially increase the risk of uncon-
cause magnesium suppresses para- uncommon, copper deficiency can lead trolled bleeding.
thyroid hormone and stimulates cal- to anemia, hypopigmentation, hyper-
citonin, it helps deposit calcium into cholesterolemia, connective tissue dis- Melatonin & St. John’s Wort
our bones, preventing osteoporosis. orders, osteoporosis and other bone
Without magnesium, calcium would defects, abnormal lipid metabolism, Extracts from St. John’s Wort have
become toxic, depositing itself in soft ataxia, and higher risk of infection. been used for centuries as an analge-
tissue, which can lead to arthritis. So, sic agent, a sedative, and a treatment
you’d think that these two miner- Fish oil and Ginkgo biloba for menopausal symptoms, anxiety,
als should be taken together, right? and depression. St. John’s Wort has
As discussed earlier, however, taking Omega-3 fish oil supplements don’t also been reported to enhance both
large amounts of minerals with other just offer heart-health benefits—they the therapeutic and adverse effects of
minerals will reduce absorption. To can also help with body weight and fat herbs or supplements with sedative
maximize your calcium and magne- reduction, vision loss, and neurocogni- properties when used concomitantly.
sium supplement benefits, aim to take tive injury. Ginkgo biloba supplements, Because melatonin is a well-known,
them at least 2 hours apart. on the other hand, have been used for potent natural sleep aid, it’s best to
the treatment of cognitive impairment avoid taking it in combination with St.
Copper and zinc (though evidence on the efficacy of John’s Wort.

Both copper and zinc are imperative for Iron and green tea them. Researchers have shown that
optimal immune health, including in- green tea can lead to iron deficiency
ternal and external healing. They work Iron is another key player when it anemia when consumed in large
comes to immune health. This ele- quantities. Likewise, iron has a nega-
ment facilitates oxygen transport, tive impact on green tea’s efficacy. In
hemoglobin formation, the break- a study led by Penn State researchers,
down of free radicals, and mito- drinking green tea after an iron-rich
chondrial respiration among other meal was shown to reduce green tea’s
processes. If you mix it with certain health benefits.
beverages, however, your body won’t
absorb the mineral. While a glass of
orange juice can help boost iron’s ab-
sorption, thanks to vitamin C, a glass
of milk can have the opposite effect
due to calcium’s interference.

Another antagonist? Green tea. Al-
though the beverage may have many
wonderful health benefits, enhanc-
ing iron’s bioavailability is not one of

THE PHARMA WORLD 65



FREEQUENTLY ASKED QUESTIONS

My child seems to suffer from ear What causes sinusitis and how is it treated?
infections a lot. Why is this?
Infection of the sinus cavities often occurs due to inflam-
Children under the age of three average one to two ear in- mation and obstruction of the sinus drainage pathways.
fections a year. These occur when fluid becomes trapped Typical symptoms of a sinus infection include facial pain
in the middle ear following a viral or bacterial infection. and pressure, nasal obstruction, yellow or green nasal
Younger children are most susceptible because their drainage, fatigue and fever. Treatment of a sinus infec-
Eustachian tubes are short and still developing, making tion may include nasal decongestants and antibiotics.
them prone to swelling and blockages. People with chronic sinus drainage may benefit from en-
doscopic sinus surgery.
What is the treatment for an ear infection?
What measures can be taken at
The majority of ear infections will run their course in home to relieve sinus pain?
about a week. Pain can be managed with over-the-
counter medications, eardrops, and warm compresses. Warm moist air may alleviate sinus congestion. Experts
If a bacterial infection is the cause, antibiotics are pre- recommend a vaporizer or steam from a pan of boiled wa-
scribed. Children who experience chronic ear infections ter (removed from the heat). Humidifiers should be used
may benefit from ear tubes. only when a clean filter is in place to preclude spraying
bacteria or fungal spores into the air. Warm compresses
My snoring is keeping my partner are useful in relieving pain in the nose and sinuses. Saline
awake. What can I do about this? nose drops are also helpful in moisturizing nasal passages.

Snoring is common. Forty-five percent of American adults When is sinus surgery necessary?
snore occasionally, and twenty-five percent are habitual
snorers. Snoring occurs when the tissues in the throat Mucus is developed by the body to act as a lubricant. In
vibrate. Lifestyle modifications such as losing weight, the sinus cavities, the lubricant is moved across mucous
sleeping on your side instead of your back and avoiding membrane linings toward the opening of each sinus by
alcohol before bedtime may help. Surgery may also be millions of cilia (a mobile extension of a cell). Inflam-
an option. Snoring is often associated with obstructive mation from allergy causes membrane swelling and the
sleep apnea, a dangerous medical condition. sinus opening to narrow, thereby blocking mucus move-
ment. If antibiotics are not effective, sinus surgery can
What is obstructive sleep apnea? correct the problem.

Obstructive sleep apnea (OSA) is a condition in which an What is a deviated nasal septum?
individual’s breathing stops periodically during sleep.
These episodes can last ten seconds or longer and may The midline of the nose consists of a cartilage and bony
occur hundreds of times each night, preventing restora- nasal septum. These separate the two sides of the nasal
tive sleep and leading to daytime fatigue, irritability and cavity. A bend or deviation in the septum can be some-
memory or concentration problems. OSA increases the thing you’re born with or can occur through injury. To cor-
risk of heart attack, stroke, high blood pressure and dia- rect this, we often perform an outpatient surgery called a
betes. We work with other medical and dental specialists septoplasty – where an incisions is made inside the nasal
to offer many treatments including CPAP, oral appliances cavity and the obstructing portion of bone and cartilage
and a variety of cutting edge procedures. is removed.

What are the signs of hearing loss? What is nasal turbinate enlargement?

Symptoms of hearing loss include difficulty understand- The nasal turbinates are three bony and soft-tissue
ing what others are saying, asking people to repeat structures lining the sides of the nasal cavity. As part of
themselves, struggling to hear in crowded places with the normal nasal cycle, the turbinates alternately swell
distracting background noise, perceiving that others are and enlarge. In some persons, the turbinates can be ex-
mumbling or not speaking clearly, listening to the televi- cessively large, resulting in significant nasal obstruction.
sion or radio at a higher volume than others and experi- Allergy treatment, typically with nasal steroid sprays,
encing a ringing or buzzing in the ears. You may find your- may help to decrease this swelling. When allergy man-
self withdrawing from social situations in order to avoid agement does sufficiently relieve nasal obstruction, the
conversation and also might experience depression. inferior turbinates can be surgically reduced. In many
cases this can be done as an office procedure.

THE PHARMA WORLD 67

ARTIFICIAL INTELLEGENCE

How AI Is Revolutionizing Health Care

The market value of AI in the AI technology can be at identifying Drug Discovery
health care industry is predict- real anomalies. Effective treatment
ed to reach $6.6 billion by 2021. of cancer heavily depends on early Drug development is a tedious ven-
Artificial intelligence is increasingly detection and preemptive measures. ture that may take years and thou-
growing in popularity throughout var- Certain types of cancer, such as dif- sands of failed attempts. It can cost
ious industries. Most of us associate ferent types of melanoma, are noto- medical researchers billions of dol-
AI with things like robots, Alexa and riously difficult to detect during the lars in the process. Only five in 5,000
self-driving cars. But AI is a lot more early stages. AI algorithms can scan drugs  that begin pre-clinical trials
than that. AI experts see it as a revo- and analyze biopsy images and MRI ever make it to human testing. And
lutionary technology that could ben- scans 1,000 times faster than doctors. only one of the five may find its way
efit many industries. The impact of AI The algorithms can diagnose with to pharmacies. Many pharmaceutical
in the health care sector is genuinely an  87% accuracy rate. Diagnosis er- giants like Sanofi and Pfizer are team-
life-changing. It is driving innovations rors and delays are becoming a thing ing up with tech companies IBM and
in clinical operations, drug develop- of the past. Google. These are  tech experts  who
ment, and surgery and data manage- are already invested in AI technol-
ment. AI technology is also rapidly Precision Medication ogy. The idea is to build a drug dis-
finding its way into hospitals. covery program using deep learning
Precision medication refers to dis- and AI. The results are already paying
Robot Doctors pensing the correct treatment de- off. Rather than using the traditional
pending on the patient’s characteris- trial-and-error approach, drug dis-
AI does not get more exciting than tics and behavior. Equally essential to covery is now data-driven. Intelligent
robots. However, these are not the correct diagnosis is the provision of simulations of better cures are pos-
humanlike droids from science fic- the appropriate treatment. This most- sible through analysis of the existing
tion films. We are talking complex ly means the exact prescription and medicine, patients and pathogens.
and intelligent machines designed for recovery routines for the best out- Researchers have even been able
specific tasks. In 2017, a robot in Chi- come. Hospitals and other health care to redirect already existing drugs to
na passed the medical licensing exam facilities collect a lot of information combat new infections. This is a pro-
using only its AI brain. In the same from their patients. The data ends cess that now takes days rather than
year, the first  semi-automated surgi- up sitting on a hard drive or in a file months or years, thanks to AI research
cal robot  was used to suture blood cabinet. AI medication systems can platforms.
vessels as narrow as 0.03 mm. Today, browse through these archives to as-
top-of-the-line hospitals are awash sist doctors  in formulating precision Personal Health Assistants
with intelligent machines. Surgical ro- medication for individual patients.
bots operate with a precision rivaling An everyday example of artificial in-
that of the best-skilled surgeons. A telligence in health care is personal
Chinese robot dentist equipped with health monitoring. Thanks to the in-
AI skills can autonomously perform ternet of medical things (IoMT) and
complex and delicate dental proce- advanced AI, there is a host of con-
dures. sumer-oriented products geared to
promoting good health. Over the last
Clinical Diagnosis few years, we have seen mobile apps,
wearables, and discrete monitors that
AI algorithms diagnose diseases fast- continually collect data and check the
er and more accurately than doctors. vitals. These gadgets use the data to
They are particularly successful in make recommendations. This is an
detecting diseases from image-based attempt to remedy any irregularities.
test results. Late last year,  Google’s Most of these devices store data lo-
DeepMind trained a neural network to cally or online. The data can be re-
accurately detect over 50 types of eye trieved and used by medical practi-
diseases by simply analyzing 3D rent- tioners as a medical report. l
al scans. This shows just how effective
Source: Forbes

68 THE PHARMA WORLD

MYTH VS REALITY DID YOU KNOW

Myth: Hearing loss affects only older people. COVID-19: Nitric oxide shows promise
Reality: Hearing loss affects people of all ages, and is as antiviral treatment
increasingly common in younger adults and children.
Only 35 percent of those with a hearing loss are 65 or An in vitro study finds that nitric oxide may suppress SARS-
older. CoV-2, the virus that causes COVID-19. The researchers sug-
gest that inhaled nitric oxide may be an effective treatment
Myth: Only very loud noises cause hearing loss. for the disease. While the world awaits a clinically proven,
Reality: Prolonged exposure to even moderately loud widely available vaccine, there is an urgent need for more ef-
noises can lead to gradual damage of your ears. fective treatments for severe COVID-19 infections.

Myth: Hearing aids make me look older. Currently, the only approved antiviral treatment for the
Reality: Today’s hearing aids are small, sleek and infection is remdesivir, which can shorten recovery time for
discrete. Advances in design and technology have some people hospitalized with COVID-19. A recent review
enabled some of them to be placed deep in the ear of the research concludes that nitric oxide, a cell signaling
canals, making them completely invisible. In many molecule produced naturally by the body, could be a
cases, others will never know you’re even wearing a potential treatment for the new coronavirus. The molecule
hearing aid. has anti-inflammatory effects and is a vasodilator, meaning
it dilates blood vessels to increase blood flow. It also has
Myth: Hearing aids won’t help with my hearing loss. antiviral properties. Previous studies show that nitric oxide
Reality: There are hearing aids designed for all levels is effective against the herpes virus, coxsackievirus, and
of hearing loss. Modern hearing aids can help 90 hantavirus.
percent of those suffering from hearing impairment,
regardless of the degree of loss. Consult with your According to a 2005 in vitro study involving cell cultures
audiologist to determine which style is best for you. grown in the lab, it also inhibits the replication of SARS-CoV.
Closely related to SARS-CoV-2, this coronavirus caused the
Myth: Hearing aids are complicated to use. global outbreak of Severe Acute Respiratory Syndrome (SARS)
Reality: Hearing aids are programmed easily based on in 2003. A small clinical study suggests that inhaled nitric ox-
your individual hearing preferences and lifestyle, and ide at low concentrations not only works as a vasodilator for
automatically adjust to different listening environ- SARS patients — improving oxygenation of their blood — but
ments. They can wirelessly connect to entertainment also as an antiviral agent.
and communication devices, offering flexibility and
ease of control. Mouthwash a promising weapon in the
fight against coronavirus transmission
Myth: Wearing two hearing aids is unnecessary.
Reality: We have two ears for a reason: they give us Readily available dental mouthwashes have the potential to
directional hearing so we can localize sounds, hear destroy the lipid envelope of coronaviruses, combating virus
better in noisy settings, and improve natural sound replication in the mouth and throat. The findings are present-
quality. Most types of hearing loss affect both ears ed in a new review article published in Function, concluding
equally; nine out of 10 people with a hearing impair- that there is an urgent need to test the effectiveness of this
ment will benefit from wearing two hearing aids. approach in clinical trials.

Myth: Hearing aids will restore your hearing to normal Ancient med colchicine—used to
levels. treat inflammatory
Reality: Hearing aids won’t reverse or cure your hear-
ing loss, but they do provide you with the ability to Ancient med colchicine—used to treat inflammatory diseases
hear better and enable you to communicate more for centuries—may curb  severe COVID-19, according to new
easily. Hearing aids can greatly improve the quality of data from a Greek  study that tested the drug in 105 hospi-
your life. talized patients. Of the 55  patients dosed with colchicine,
only one grew sicker, while seven of the 50 on antivirals and
Myth: Hearing aids will whistle in your ear. antibiotics alone  became severely ill. American  physicians
Reality: Today’s modern digital hearing aids are able to agreed the trial had its limits, but additional U.S. studies are
distinguish the differences between speech and back- underway to test the old drug against the novel virus.
ground noise, and successfully eliminate the whistling
associate with older, analog devices in the past.

THE PHARMA WORLD 69



TECHNOLOGY

Top Robot Uses AI to Make Blood,
Draws, Insert Catheters

Researchers at Rutgers University tomatically find blood vessels, even if near-infrared imaging to image the
have developed a robot that uti- they are very small, and successfully tissue, and artificial intelligence to in-
lizes artificial intelligence, along insert a needle or catheter. terpret the images and detect blood
with near-infrared and ultrasound vessels and calculate their depth and
imaging, to automatically make blood The robot is small enough to sit on size. l
draws and insert catheters in small a benchtop and uses ultrasound and
blood vessels. The device could take
the guesswork out of blood draws,
which are frequently challenging
when performed manually, and re-
duce the chances of complications,
while allowing medical staff to focus
on other tasks.
As healthcare staff can find it dif-
ficult to see the vein they are attempt-
ing to access, complications can arise
when other structures are damaged
by a needle insertion, such as nearby
arteries, organs, or nerves. To address
these issues, the Rutgers researchers
created a robotic system that can au-

Handheld Eye Scanner to Detect Autism Spectrum Disorder FDA Clears First Pulse Oximeter
to Measure Breathing Rate
Researchers at Flinders very young children, after one of his
University in Australia have own children was diagnosed with the Masimo just received
developed a handheld eye condition. the first FDA clear-
scanner that could help to ance for a fingertip
identify children with au- “Very early diagnosis means not pulse oximeter that
tism spectrum disorder. only can children receive important can measure respira-
The device allows clinicians interventions, but families are em- tion rate. The Mighty-
to obtain light-adapted powered to get the necessary sup- Sat Rx spot-check
electroretinograms, which ports in place, come to terms with the pulse oximeter in-
involves detecting electri- diagnosis, and make informed deci- cludes a technology
cal signals in the retina. sions,” said Constable in a Flinders known as Respiration Rate from the
The device could help in di- press release. l Pleth (RRP) that makes it unnecessary
agnosing children with au- to perform manual counts or use chest
tism much earlier, meaning electrodes to measure respiration rate.
that they can get appropriate support
as soon as possible. The device can be used in the clinic,
but is now also indicated for at-home
Parents who have had one au- use. In addition to respiration rate, it
tistic child have a higher chance of measures oxygen saturation, pulse
having a second, and early diagno- rate, perfusion index, and Masimo’s
sis would be very valuable for such Pleth Variability Index (PVi). It also
families. features the company’s well-known
Measure-through Motion and Low Per-
One of the researchers behind the fusion SET capabilities that continue
device, Dr. Paul Constable, has been to provide accurate data in challenging
searching for an autism biomarker patients and conditions. l
since 2006 to help with diagnosing

THE PHARMA WORLD 71

APPOINTMENTS & PROMOTIONS

DR. SAYEED AHMED has re- MIRZA KHORSHED ALAM MD. MAMUNUR RAHMAN SYED NAIMUL HASSAN
cently joined as Director Sales recently joined as Head of recently joined as Head of CHOWDHURY has recently
& Marketing at Navana Phar- Sales at Everest Pharma- Marketing at Everest Phar- joined as Assistant General
maceuticals Ltd. Prior to this, ceuticals Ltd. Previously he maceuticals Ltd. recently Manager (AGM) at Strategic
he worked as Head of Market- served as Sales Manager with the major portfolios of Brand Management Depart-
ing at The ACME Laboratories at General Pharmaceuti- marketing divisions. Prior to ment (SBMD), Navana Phar-
Ltd. as well as Head of Sales cals Ltd. He completed his this, he was the DGM, Mar- maceuticals Ltd. Prior to this,
& Marketing at Ziska Pharma- B.Pharm & M.Pharm from keting at Pharmasia Ltd. of he had been working in The
ceuticals Ltd. He started his Jahangirnagar University. Sony-Rangs Group. Acme Laboratories Limited at
career in marketing at Incep- He has around 20 years of Strategic Brand Management
ta Pharmaceuticals Ltd. Dr. successful Marketing, MSD He also worked as the Department (SBMD), lastly as
Sayeed Ahmed did his MBBS & Sales career. Head of Marketing & Sales in Senior Manager. He started
from Mymensingh Medical Asiatic Laboratories Ltd. He his career in The Acme Labo-
College. He has experience of KHONDOKAR JAMAL also served as Senior Man- ratories Limited as Product
18 years in Marketing & Sales ager of Pharma & Health- Executive at Strategic Brand
in pharmaceutical industry. HOSSAIN has recently care SBU of Orion Group. Management Department in
2007. He has experience of
MD. AKRAMUL KABIR has joined as Manager, PMD at He is also one of the over 13 years in Pharmaceu-
recently been promoted as few marketing profession- tical Marketing.
Marketing Manager in UniMed One Pharma Ltd. Prior to als having vast expertise in
UniHealth Pharmaceuticals healthcare related business GOPAL KUMAR DAS
Ltd. Previously, he was Group this, he served as Deputy activities with the strong has recently joined as Dep-
Product Manager in the same expertise in execution of uty Manager, SBM at Everest
organization. He obtained Manager, PMD at Biophar- ATL, OTL & BTL promotional Pharma Ltd. Prior to this,
his B. Pharm from Northern strategies with the many he was working at Orion
University Bangladesh and ma Limited. He started his trend setting innovation of Pharma Ltd. and Unimed
M. Pharm from University of the pharma brands. UniHealth Pharma Ltd. He
Development Alternative. He career in Product Manage- completed his B.Pharma
has been contributing in the With a marketing track and M.Pharm from Jahangir-
area of Bangladesh Pharma- ment Department at the record of over 20 years of nagar University.
ceutical Marketing for more experience in Pharma Mar-
than a decade. same organization. He ob- keting including Export, Vet-
erinary & Herbal-Ayurveda
tained his Bachelor degree & Nutraceuticals. Rahman
left his footprint in all the
under pharmacy Depart- disciplines he worked. He
did his graduation and
ment of Gono University post-graduation in Phar-
macy from Jahangirnagar
and MSc in Pharmaceutical University & did MBA from
the University of Dhaka.

technology from University

of Asia Pacific.

72 THE PHARMA WORLD

APPOINTMENTS & PROMOTIONS

MD. ABDUS SALAM has re- DR. RAIATUN TEHRIN has re- HOSSAIN SHAHID NUTON CHOWDHURY has
cently joined as Deputy cently joined as Deputy Man- has recently joined as Assis- recently joined as Assistant
Manager at Strategic Brand ager at Strategic Brand Man- tant Manager, SBM at Ever- Manager of Learning & Skills
Management Department agement Department (SBMD), est Pharma Ltd. Prior to this, Development department in
(SBMD), Navana Pharma- Navana Pharmaceuticals Ltd. he was working at ACI Ltd. Everest Pharmaceuticals Ltd.
ceuticals Ltd. Prior to this, Prior to this, she worked in He completed his B.Pharma Before this, he served as Sr.
he had been working in ACME Laboratories Ltd. and and M.Pharm from Jahangir- Group Manager in General
General Pharmaceuticals Ziska Pharmaceuticals Ltd. Af- nagar University. Pharmaceuticals Ltd. He also
Ltd. since 2011 at Strate- ter doing MBBS, she did post- worked as Q.A officer in Incep-
gic Marketing Department graduation in public health. ta Pharmaceuticals Ltd. He did
(SMD), lastly as Assistant Before exploring pharmaceu- his B.Pharm & M.Pharm from
Manager for 2.5 years. He tical industry, she worked as University of Asia Pacific.
started his career as Prod- a faculty in Biochemistry and
uct Executive at Marketing community medicine in 3 Med-
Strategic Department, Ziska ical Colleges of Bangladesh.
Pharmaceuticals Ltd. in She also worked as a medical
2009. He has experience of office in a hospital. She has a
over 11.5 years in Marketing total experience of 10 years in
in pharmaceutical industry. different disciplines.

BRIFAT ARA YASMIN BITHY NAIMA NUSRAT JAHAN has re-
has recently joined as Ex- cently joined as Brand Execu-
ecutive of Learning & Skills tive, at Everest Pharmaceu-
Development Department, ticals Ltd. Naima completed
at Everest Pharmaceuticals her B. Pharm (Professional)
Ltd. Brifat completed her B. and M. Pharm from Jahangir-
Pharm (Professional) and M. nagar University.
Pharm from Jahangirnagar
University.

MD. SHARIFUR RAHMAN re- SARDER ARIFUZZAMAN has TANMOY DEBNATH has re-
cently Joined as Assistant recently joined as Sr. Brand cently joined as Brand Exec-
Manager, FSD at Everest Executive at Everest Pharma- utive at Everest Pharmaceu-
Pharmaceuticals Ltd. Prior ceuticals Ltd. Prior to this, he ticals Ltd. He completed his
to this, he worked as Assis- worked as Researcher at Han- B.Pharm (Professional) from
tant Manager, at Apex Phar- yang University (South Korea). Jahangirnagar University.
ma Ltd. He has more than 9 He also served as Sr. Executive
years of experience in Phar- in Orion and Square Pharma-
maceuticals Sales Admin. ceuticals Ltd. He completed
He completed his MBA from his B. Pharm. and M.S. in Phar-
Southeast University. maceutical Science from Ja-
hangirnagar University.

THE PHARMA WORLD 73

APPOINTMENTS & PROMOTIONS

INNOVATION

MD. THAUFIKUR AHOSHAN Top 10 Innovation Trends in
CHOWDHURY has recently Pharmaceutical Industry
joined as Brand Executive at
Everest Pharmaceuticals Ltd. Pharmaceutical (Pharma) indus- In these times of rapid changes, for
He completed his B.Pharm try is a set of public and private Pharma companies it is not enough
(Professional) from Jahangir- organizations that discover, de- to focus solely on selling drugs and
nagar University. velop, and manufacture drugs and medications. Today the industry aims
medications (pharmaceuticals). The for more holistic approach with inte-
JOYA BISWAS has recently 19th century is the beginning of the grated services, customization and
joined Everest Pharmaceuti- modern era of the pharmaceutical changes in life-styles. It leads to the
cal Ltd as a Brand Executive. industry, because then it started fo- trends, to which Pharma companies
Prior to this, she worked at cusing on chemical synthesis. Prior either have to respond to, or then to
The ACME Laboratories Ltd to that, for thousands of years peo- vanish. Top 10 Innovation Trends in
for a year. She completed ple relied on medicinal properties of Pharmaceutical Industry is an exqui-
her B.Pharm from Gujarat plants, animals, and minerals. The site opportunity to learn how Pharma
Technological University, 20th century marks the unification Industry is shifting to more digitized,
Gujarat, India. of chemistry and physiology, which customized and personalized era.
increased the understanding of basic
MD. ANAN CHOWDHURY has drug-discovery processes. Today the The list of the Top 10 Innovation
recently joined as Brand Ex- pharmaceutical industry discovers Trends in Pharmaceutical Industry
ecutive, at Everest Pharma- myriad of drugs to prevent and treat
ceuticals Ltd. He completed even most complicated illnesses, – Prevention Over Treatment
her B. Pharm from BRAC while facing challenges of attaining – Turning Back to Nature: Biological Labs
University. regulatory approvals, confidentiality – Reverse Innovation
and pressure from patients. – Crowd-sourcing the Solutions:
74 THE PHARMA WORLD The reason is, that pharmaceutical
industry is overly regulated, in order Empowered and Know-How Patients
to ensure that medications are safe – Open Innovation
to consume. Furthermore, most of – Nano Technology
pharma companies have extremely – Personalized Medicine and
strict internal policies, which restrict
them from sharing the data with the Customization
others. It slows down the processes – 3D Printing
dramatically. – Artificial Intelligence and Cognitive

Computers
– Body Sensors

Source: GIMInstitute
– WHO

HEALTH TIPS

Coffee associated with improved
survival in metastatic
colorectal cancer patients

In a large group of patients with metastatic colorectal cancer, con-
sumption of a few cups of coffee a day was associated with longer
survival and a lower risk of the cancer worsening, researchers at
Dana-Farber Cancer Institute and other organizations report in a
new study. The findings, based on data from a large observation-
al study nested in a clinical trial, are in line with earlier studies
showing a connection between regular coffee consumption and
improved outcomes in patients with non-metastatic colorectal
cancer. The study is being published by JAMA Oncology.

Can an apple a day help keep
cancer away?

Researchers found that people who frequently eat fruit often
have fewer tumors. Apples are one of the fruits that boast a large
amount of dietary fiber and polyphenol compounds that part-
ner with gut microbes to create an environment that may reduce
one’s risk of cancer. This environment is predicted to reduce the
risk of several specific cancers, including lung, bowel, mouth, di-
gestive tract, and breast tumors, when compared to people who
do not consume apples regularly. The vitamin C in apples also
acts as an antioxidant to support immune function and fight
cancer cell growth. In addition to preventing tumors, apples may
also support cancer recovery. The amount of potassium found
in apples can positively affect one’s fluid balance and prevent
fluid retention, which is a common side effect of chemotherapy.

The 7 Best Foods for Fighting
Inflammation

Inflammation is our body’s healthy response to
fighting disease. But when it gets out of hand, in-
flammation can become chronic and lead to a
whole host of health problems, from autoimmune
diseases to cancer. Foods high in sugar and satu-
rated fat are thought to contribute to inflammation,
which is why some people who have inflammatory
conditions and autoimmune disorders try out low-
sugar diets.

On the flip side, there are also foods to pile onto
your plate that may actually tamp down inflamma-
tion. These are the best foods for fighting inflam-
mation: Bell peppers, Pears, Mackerel, Spinach,
Black tea, Buckwheat, Pomegranate seeds.

THE PHARMA WORLD 75



EXPORT

Pharmaceutical Importers in Myanmar

Appended below is a partial list Pharmaceutical Importers/Distributors in Myanmar

Three Stars Co., Ltd. Great Luck Co., Ltd. Win Pharmacy Co., Ltd.
No. 21, 21st Street, Latha Township 36, 19th Street, Latha Township, 207, 1st floor, Bosunpet Street
E-mail: [email protected] Yangon, Myanmar Pabedan Township,
E-mail: [email protected] Yangon, Myanmar
Asia World Company Limited E-mail: [email protected]
No.61-62 Bahosi Development Lion Myanmar International Co. Ltd.
Wada Street, Lanmadaw Township 314(A), U Wizara Road, Winged Pyinsa Trading Co., Ltd.
Yangon, Myanmar Kamayut Township, Yangon, Myanmar Room (40), Building No. 2
E-mail: [email protected] E-mail: [email protected] 8 Miles Junction,
[email protected] [email protected] Mayangone Township,
[email protected] Yangon, Myanmar
Medi-tech Trade Centre E-mail: [email protected]
Min Zar Ni (Pharmaceutical) Co. Ltd. Room No. 1102,
23-B, Kwin Kyaung Road, Ahlone Shwe Gon Thu Condominium (A1), Yi Shin Co., Ltd.
Township Lower Kyee Myin Dine Street, 25-26, Bahosi Housing Complex,
Yangon, Myanmar Kyee Myin Dine Township, Lanmadaw Township,
E-mail: [email protected] Yangon, Myanmar Yangon, Myanmar
[email protected] E-mail: [email protected] E-mail: [email protected]
[email protected] [email protected]
Australasia Marketing Trade &
Technology Co. Ltd. Medilink Co., Ltd. Zabu Tun Trading Enterprise Ltd.
No.2,Aung Mingala Road, 4th Quarter No. 128, Banayardala Road No. 10, Pyithaya Road, Bauktaw,
Mayangone Township. P.O. Kandawglay (11221) Yankin Township, Yangon, Myanmar
Yangon, Myanmar Mingala Taung Nyunt Township, E-mail: [email protected]
E-mail: [email protected] Yangon, Myanmar
[email protected] E-mail: [email protected] Zar & Zar Co., Ltd.
Level-13, Road 1306, Olympic Tower II
Concordia Medical System Configure Housing Ltd. Bo Aung Kyaw Street,Township
Ground/3rd, 4th, 5th floor. Fail Deal Trading Co. (Pvt) Ltd. Yangon, Myanmar
Shwe Gon Plaza House Nol. 32, 2nd floor E-mail: [email protected]
Kabaaye Pagoda Road, 165th Street, Yangon, Myanmar [email protected]
Bahan Township, Yangon, Myanmar E-mail: [email protected]
E-mail: [email protected] Zifam Ply Ltd.
[email protected] Myanmar Chemdyes Co., Ltd. 190, 192, 5-H, 5th floor,
No. 126, Mahabandoola Garden Street Dagon Tower, Shwe Gon Dine
Evergreen Trading Co., Ltd. Kyauktada Township, Bahan Township, Yangon, Myanmar
20€, 1st floor, 56th Street Yangon, Myanmar E-mail: [email protected]
Pazundaung Township, E-mail: [email protected]
Yangon, Myanmar [email protected] Asia Winner Industrial Ltd.
E-mail: [email protected] 13, 49th Street, Botahtaung Township
United International Agencies Yangon, Myanmar
Fortune International Ltd. Indenting & Manufacturing Repre- E-mail: [email protected]
11-12, Bahosi Complex, sentative [email protected]
Bagyoke Aung San Road, 07-702, Olympic Tower,
Lanmadaw Township Bo Aung Kyaw Street Golden Hawks International Ltd.
Yangon, Myanmar Kyauktada Township, No. 153, Anawrahta Street
E-mail: [email protected] Yangon, Myanmar Botataung Township,
[email protected] E-mail: [email protected] Yangon, Myanmar
[email protected] [email protected] E-mail: [email protected]

THE PHARMA WORLD 77

REGISTRATION RULES

WISH TO EXPORT
TO BAHRAIN?

The agent or the company
representative should provide
the following documents for the
registration of a pharmaceutical
manufacturer or its site.

Item 1 Registration does not cover whole- along with a brief description of
salers and distributors. Marketing these
1. Full profile of the Company in- authorization holders should have 3. Full index of contents of the files
cluding kinds and scope of activi- a manufacture licence issued by the
ties. health authorities in country of origin. Item 4

2. Number of manufacturing sites Item 2 Source of starting material should be
owned by the company and their clarified.
addresses. In case of failure to meet GMP require-
ments after a GMP inspection visit, a Item 5
3. The kind of legal and commercial 12-month period should elapse be-
relationship the company holds fore reconsidering the case. The product label should carry the
with these different sites. following information on external and
Item 3 internal pack in English/Arabic-
4. Manufacturing licence number - Proprietary name followed by com-
and its date in country of origin MOH authorities should be informed
about any sale, merge, take or take mon name of active ingredient(s)
5. List of all products marketed by over or any legal or commercial ac- - Pharmaceutical form and strength
the company tion concerning the company or its - Contents by common flame and
site within 90 days of the action.
6. Agency Contract quantities per dose
PRODUCTS - Pack size by weight, volume, or
7. GMP certificate from the health
authorities in the country of the The applicant should submit a de- number of doses.
site scription of the submitted documents - List of excipients with certain phar-
as follows:
8. Number of employees in the dif- 1. Number of submitted files maceutical function
ferent sections and their qualifi- 2. Number of samples submitted - For injectables, eye drops, and ex-
cation.
ternal use products all excipients
9. Graphic design of the site and should be mentioned
flow of manufacturing lines - method of use
- warnings
10. List of all products the site pro-
duces either on its vicinity, or
through contract manufacturing
with or for other marketing au-
thorization holders (NIAH’s)

11. Clarification of the relationship
with the MAH.

12. Any inspection visit report by GCC
health authorities or Arab Health
Authorities, except for country of
origin if it is an Arab country/site.
Otherwise, a GMP inspection visit
should be arranged.

78 THE PHARMA WORLD

- expiry date by month & year - probable allergy-producing ad- health authorities in country of origin
- Special storage requirements dresses stating the following:
- marketing authorization holder
- manufacturer of the finished prod- - dose and dose regimens - ex-factory price.
- clear description of administration
ucts - wholesale price in country of origin
- batch number method
- In case of OTC drugs, clear method - antidote and treatment of overdose - public sale price in country of origin
- any information related to period
of use should be specified. - ClF price GCC countries
- In case of blisters, proprietary of use, skipping or forgetting dos-
es, abrupt withdrawal, best time of - suggested ClF price to Bahrain
name, common name, marketing administration of doses, etc.
authorization holder, batch num- - side effects and advice on report- Item 12
ber and expiry date should be ing any adverse reaction to doctors
mentioned and pharmacists 1. Stability studies should be at-
- ln case of small containers such - warning against use after expiry tested by quality assurance section
as ampoules the following should date on Pack and authorized by manufacturer.
appear on the label (as minimum - number of leaflet and date of last Stability studies should be con-
requirement) revision ducted on the product in the same
- name of drug, strength, route of container closure system intended
administration Item 7 for marketing in Bahrain.
- manufacturer name and/or logo
- method of use A full bioequivalence study report or 2. Stability studies should be provid-
- expiry date equivalent, from an independent lab ed for at least 3 production batch-
- batch number should be submitted whenever a ge- es, the following should be clarified
- contents by weight, volume or units neric product is submitted for registra- at the beginning of the document
tion. For registration of under-licence
Item 6 products for out-of-patent molecules 3. Tests should cover physical, chemi-
a bioequivalence study comparing it cal, biological and microbiological
The product patient leaflet should with the parent product is required. attributes.
contain the following in English/Arabic
- brand name followed by common Item 8 4. For accelerated stability studies,
testing should be done at certain
name Products imported for government time points: initial, 3 and 6 months
- pharmaceutical form and concen- outlets and in large pack sizes should at least. If there is a change in the
carry the full medical profession leaf- specifications, then testing should
tration or strength let. In case this could not be met and be done at intermediate condi-
- qualitative and quantitative infor- patient leaflets ate supplied in the tions at four points of time: kiital,
pack, extra medical profession leaf- 6, 9 and 12 months (this includes
mation about active ingredient(s) lets should be submitted to the Min- initial and final readings)
and excipients in common name istry of Health for distribution upon
- pack size and contents by volume, request. 5. Real time should cover at least 12
weight or number of dosage months duration at long term and at
- pharmacotherapeuetic group in Item 9 least 6 months data at intermediate
clear understandable language. storage condition. For zones I and II,
- MAH and manufactudnglicence If the pharmaceutical product contains /long term conditions are 25ºC±2 ºC
holder an animal product the source and kind and 60%±5% RH. For Zones III and
- therapeutic indication(s) of animal should be specified. IV, long terms conditions are term
- contra indication(s) conditions are 25ºC±2 ºC 60%±5%
- precautions Item 10 RH. Which is the same as the inter-
- drug-drug interaction, food inter- mediate conditions
action, alcohol drug interaction Only approved colouring substances,
and others. flavouring substances, diluents and 6. Stability studies conditions: Long-
- any special precautions additives should be used in the manu- term
- use during pregnancy, lactation, facturing process as approved by ma-
elderly, children and other patient jor drug regulatory agencies, WHO and REGISTRATION
categories other international organizations.
- effect on driving and machinery The cancellation of a manufacturer’s
operating Item 11 registration is done under any of the
following conditions:
Price certificate authenticated by the 1. If it has not submitted any of its

products for registration within a
year of the company registration.
2. If forgery in its papers and docu-
ments has been proven.
3. If it has violated the regulations
and guidelines of GMP. l

THE PHARMA WORLD 79



POST-EVENT

TEST YOUR The FIRST OnLine edition
of 3rd Arab Pharma
KNOWLEDGE Manufacturers’ Expo

Take a quick quiz to see The FIRST OnLine edition of the The first ever VIRTUAL
how you’re doing 3rd ARAB PHARMA MANUFAC- EXHIBITION of the Arab region
TURERS’ EXPO 2020 - an inter- exclusively on complete
1. How far apart should you national exhibition on complete pharma manufacturing
keep from others? pharma manufacturing focusing Ara-
Distance is not an issue, I can get close bic countries in Middle East & North l 1 OnLine Exhibition
At least 1 metre away from others Africa (MENA) region drew attention
At least 4 metres away from others of Buyers and trade professionals l 18 Arab countries pharma
of 24 countries to virtually meet the markets
2. How long should you wash your exhibiting companies for business
hands with soap and water? networking and to attend the Tech- l 67 exhibiting companies
15 seconds nology Presentations.
40 seconds Keeping in mind the health adviso- l 470+ Products / Services
1 minute ries by the Government due to the Categories
pandemic, the OnLine Exhibition
3. How do you cover a cough or integrated all the basic essential l 520 Trade Buyers from 24
sneeze? features to the exhibiting compa- countries
With my cupped hand nies to generate optimum output
I put my head down and away from others in terms of display and communi- spanning over 6 days alongside the
Into my bent elbow cation while participating in highly OnLine Exhibition had remained
cost effective manner, says the highly resourceful for pharma man-
4. When should I wear a mask? Press release. ufacturing fraternity to acquire the
A mask is not needed technology based information.
When I have to be closer than 1 metre 67 exhibiting companies from 8
from others I am not living with countries displayed products / ser- Overall, the Exhibitors well ap-
Only when I am in a closed room with vices under 470 sub-categories un- preciated the novel concept of the
many other people der 18 major sections for the latest OnLine Exhibition, as it applies all
pharma manufacturing. The Buyers the latest technical aspects to offer
srehto morf yawa ertem 1 tsael tA .1 registered and attended the OnLine the optimum business networking
Exhibition from Algeria, Egypt, Iraq, domain bypassing all the limitations
sdnoces 04 .2 Israel, Jordan, Lebanon, Libya, Mau- (Social Distancing, Travel, Logistics,
ritania, Morocco, Palestinian Ter- Vulnerability to infectious diseases,
woble tneb ym otnI .3 ritory, Qatar, Saudi Arabia, Sudan, and many more associated risk fac-
Syria, Tunisia, Turkey, Yemen, UAE. tors).
ertem 1 naht resolc eb ot evah I nehW .4 The pharma manufacturing profes-
htiw gnivil ton ma I srehto morf sionals from other countries like UK, ARAB PHARMA MANUFACTUR-
USA, India, Kenya, Ethiopia, and Ni- ERS’ EXPO 2020 (OnLine Exhibi-
geria had also visited and witnessed tion) is jointly organized by AUPAM
the first ever OnLine Exhibition on (Arab Union of the Manufacturers of
the COMPLETE pharma manufactur- pharmaceuticals and Medical Appli-
ing technologies focusing the Arab ances) and GPE EXPO PVT LTD, and
region. is supported by Indian Drug Manu-
facturers’ Association (IDMA). To ob-
More than 45 Live Technology tain more information, please email
Presentations addressing the lat- to: [email protected].
est trends and current practices of Event Catalogue (Digital Edition) can
pharma manufacturing technolo- be downloaded from: Events.ArabP-
gies by the exhibiting companies harmaExpo.com l

THE PHARMA WORLD 81