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1. BIOSIMILARS
EMERGING MARKET IN INDIA
1
Presentation by :
U.PRUTHVIRAJ
Roll.no.43
DOPM
NIPER, MOHALI.

2. INTRODUCTION
 The Indian Pharmaceutical Industry has been a global leader in
the cause of providing high quality affordable medicines to the
world
 The first generation of biological drugs, which have introduced
many revolutionary treatments to life-threatening and rare
illnesses, is currently facing patent expiration
 The similar biologics industry, globally has been growing
stupendously ,but still in its infancy
2

3. • Therapeutic products typically derived
from living systems and can also be
produced by using biotechnological
procedures.
Biologic
• A biological product produced by
biotechnological methods and claimed
to be “similar” in terms of
safety, efficacy and quality to a
reference biologic, which has been
granted a marketing authorization in
India
Similar biologic
3
Officially approved subsequent version of innovators biologics
after expiry of patent

4. • „Biosimilars‟.
Europe- EMEA
• ‘Fallow- on Biologics’
US- FDA
• „Subsequent Entry Biologics’ (SEBs).
CANADA- BGTD
4

5. • Similar biologics
INDIA
5

6.  Global sales of biologics US $ 157 billions,2012
 Global sales of biosimilars US $ 693 million,2012
6
 Indian biologics market crossed US $ 3 billion,2011-12
Source : Global use of medicines outlook through 2016, IMS HEALTH-JULY2012
MARKET OVERVIEW
Source : Ministry of external affairs,GOI
Indian biosimilar market

7. BIOLOGICS
CORE THERAPY AREA OF BIOLOGICS MARKET
( $ US BILLION)
Insulin 15.9
Anti-TNF 15.8
Oncology 12.5
EPO 7.6
Multiple sclerosis 7.3
CSF-G 5.0
Blood coagulation 3.1
Ocular antineovascular 2.0
Anti viral (no-HIV) 1.5
Others 16.5
7
Source : IMS HEALTH 2011

8. TOP BIOLOGICS
8
BRAND
Source : FIERCE PHARMA

9. Regulatory guidelines set by :
INDIA
DBT
CDSCO
U.S
FDA
EUROPEAN
UNION
EMEA
9

10. EUROPE :THE FIRST MARKET
 Today, the continent is the largest biosimilars market in the
world with robust guidelines
 EMEA( European Medicines Authority)
 Reviews marketing authorization applications for biologics.
 Award either positive or negative opinion based on evaluation
of quality, safety and efficacy measures
 After the product receives a positive opinion EC(EUROPEAN
COMMISION) will grant marketing authorization valid for the
European union.
 Sandoz/Novartis, Stada, Hospira, Medice and Teva.
10
1st biosimilar - Omnitrope in 2006 for Somatropin(HGH)

11. US MARKET
 Largest Biologics market
 The Patient Protection and Affordable Care Act , March 23rd
2010
 Public Health Service Act
 The U.S. FDA issued three draft guidance documents on
Feb 9th ,2012
11

12. INDIA
12
AUGUST 15th ,2012

13. COMPETENT AUTHORITIES INVOLVED IN
APPROVAL PROCESS
 RCGM(Review Committee on Genetic Manipulation)
 Functions in Department of Biotechnology( DBT), Ministry of
Science & Technology, Government of India(GOI)
 Responsible for authorizing import & export for R&D and
review of data up to preclinical evaluation
 GEAC(Genetic Engineering appraisal Committee)
 Functions under ministry of Environment & Forests
 Responsible for review & approval of activities involving
large-scale use of genetic engineered organisms & products
there of in R&D , industrial production , environmental release
and filed applications
13

14.  CDSCO ( Central Drugs Standard Control Organization)
 Headed by DCGI under Ministry of Health & Family Welfare
 Responsible for clinical trail approval ,permission for
marketing, manufacturing and grant of import& export
license
 State FDA works with CDSCO in each state & is responsible
for issuance of license to manufacture similar biologics in
India
14
Source : Guidelines on Similar Biologics:
Regulatory Requirements for
Marketing Authorization in India, GOI, 2012
GOI prepared this guidelines by referring EMEA guidelines, ICH
guidelines, WHO guidelines

15. Head-to-head characterization studies are required to compare
the similar biologics and the reference biologic
15
GMP
standard
s
Quality
test
pre-
clinical
testing to
GLP
clinical
testing
to GCP
Post
marketing
safety
APPROVAL PROCESS

16. Continued..
16
Reference biologic should be licensed in
India
In case, Reference biologic is not marketed
in India, 4years market exclusivity given for
innovator product .
This period of 4 years may be reduced in
case of National Healthcare Emergency

17. FORCES SHAPING THE BIOSIMILARS MARKET
Biologics patent expiries Rising Health Costs
Burgeoning aging
population and diseases
like cancer, diabetes & R.I
Price of biologics
BIOSIMILARS
MARKET
17
cost-effective alternatives to biologics reflects the growing demand for these
speciality drugs

18. 18

19. HURDLES
TECHNOLOGI
AL BARRIERS
INTERCHANG
EABILITY
UNCERTAIITI
ES
HIGHER
GESTATION
PERIOD
HIGH COST
TO DEVELOP
19
Average cost estimates range from
US$80-120 million
Reluctance from physicians
to prescribe and use
biosimilars
Sophisticated technologies &
processes
Cost of Biosimilars products to consumers in emerging markets is still
relatively high unlike small molecule generics that are at heavy discounts
to originators.

20. OPPORTUNITIES
Oligopolistic market
Less entry of Competitors
Government initiatives to encourage
Biosimilars.
20

21. Companies should clear of
their strategic relevance within the organization
Portfolio fit Financial suitability
Therapy areas-size of
potential
Synergies with the value
chain
THOSE LOOKING FOR JOINING BIOSIMILARS JOURNEY..

22. Clinical
development
Market access
Manufacturing
costs
Sales and
marketing
22
VALUE CHAIN

23. INDIAN SCENARIO
While almost all major Indian drug makers have outlined plans, identified
products and set aside investment budgets to develop a robust product
pipeline, some have even started rolling them into the market.
23
About 20 Indian
companies entered
into market
Presently , there
were about 15
epoetin, 8 G-CSF
and 4 insulin
biosimilars available

24. INDIAN COMPANIES
24
The current biosimilars portfolio of Dr Reddy‟s Laboratories constitutes of
filgrastim, peg-filgrastim, Rituximab and Darbepeotin alpha, which have
commercial presence in 13 emerging countries.
“Soon, I expect to see Dr Reddy’s biosimilars entering developed markets,”
Chairman K Anji Reddy says.
Lupin is now on its way and plans to soon launch its first of two biosimilar drugs
for oncology in India by the end of this year. The company currently has a total
of 10 proteins in different stages of development
Reditux, a copy of Rituximab
manufactured by Dr.Reddy‟s,has been
available in India since 2007
1st
biosimilar
in INDIA

25. Cipla are making huge investments in India and outside to
acquire manufacturing facilities and potential product
pipelines in the biosimilar segment
25
 Wockhardt is among the early entrants and has developed
insulin and analogues
Recently opened a large biotech park in
AURANGABAD, designed according to U.S & EMEA
Standards
Ranbaxy, Biocon, Shantha Biotech, Reliance Life Sciences, Panacea Biotec
and Intas Biopharmaceuticals are also on the way

26. 26
Ranbaxy holds 40% stake
in Zenotech for marketing
biosimilars
Developing antibodies
March 2012, Biocon and Pfizer had
amicably concluded their alliance to
commercialize Biocon‟s biosimilar
versions of Insulin and Insulin analog
products
Co-develop and market the low-cost
version of a biotech cancer medicine
filgrastim (G-CSF) in North America and
Europe

27. 27

28. CONCLUSION
 The biosimilars market is in the nascent stage of the industry life
cycle with limited market and product development experience.
However, there is a significant market opportunity from patent
expiries
 High initial investments are still a major barrier for new entrants.
 Collaborations among large pharmaceutical companies with
financial capabilities and specialty biotech companies with technical
expertise are expected
 The strong integration of marketing and research and development
skills is the key to success in the biosimilars market.
28
Companies need commitment, along with a well-charted strategic
plan, investment and technical synergy because biosimilars is a long-term
game, with many hurdles on the way.

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