This document discusses biosimilars in India and the opportunities and challenges in the biosimilars industry in India. It defines biosimilars and provides an overview of the global and Indian biosimilars market and regulatory landscape. The key opportunities for India include providing affordable treatment options and commercial benefits from lower cost manufacturing. However, challenges include regulatory hurdles, concerns around quality and safety, high development costs, and physician reluctance to prescribe biosimilars.

1. BIOSIMILARS
INDIAN PERSPECTIVE AND
ROAD AHEAD

2. BIO - PHARMACEUTICALS
Biological / Biotech Therapeutic Drugs
Produced in Living Organism
Using genetic engineering-r
DNA technology
Replace or supplement natural
Protein produced by the body
like insulin
BIOTHERAPEUTICS CONVENTIONAL DRUGS
Manufacturing
Process
Complex Biological
Process
Chemical Synthesis
Mol. Weight 5000-200,000 Daltons 10-1000 Daltons
Structure and
Complexity
Complex Spatial Structures Simpler Structures
Cost High Relatively Low

3. BIO - SIMILARS
Legally approved subsequent versions of innovator biopharmaceutical
products made by a different sponsor following patent & exclusivity
expiry of the innovator product.
Name Country Definition
Similar biologics INDIA Similar in terms of safety, efficacy and quality to a reference
biologic, which has been granted a marketing authorization in
India
SBP
(Similar Biologic Product)
WHO Similar to an already licensed reference biotherapeutic
product in terms of quality, safety & efficacy
FOB
(Follow-On Biologic)
US-FDA Highly similar to the reference product without clinically
meaningful differences in safety, purity and potency
SEB
(Subsequent Entry
Biologic)
CANADA Drug that enters the market subsequent to a version previously
authorized in Canada with demonstrated similarity to a
reference biologic drug
• It should be a biologic product
• The reference product should be an already licensed biologic product
• The demonstration of high similarity in safety, quality & efficacy is
necessary

4. SIMILAR NOT IDENTICAL
• Manufacturers have access to the Final Product Only
• Process Details for the production of Reference Product are not available
• Each Manufacturer designs their own process based on:
• Different CELL LINES
• Different PROCESS STEPS
Biosimilars are Similar…
…Not Identical
CAN WE REFFER BIOSIMILARS AS
BIOGENERICS?
• In Theory Yes We can
• But due to structural & manufacturing
complexities, these biological products are
considered as similar, but not generic
equivalents of innovator biopharmaceuticals

5. GLOBAL SCENARIO
• In 2010, sales of biologics
were around $100 billion
worldwide with the top 12
biologics generating $30
billion
• More than 200 Biologics
are already in market
• By 2015, biologics
responsible for $ 80 billion in
annual sales will go off
patent
• Global market for
biosimilars was $311 million
in 2010 & expected to
increase to $ 10 billion in
2015
Patent Expiration Dates of Some Biologics
Biologic INN Name US Expiration EP Expiration
HUMANIZED ANTIBODIES
Avastin Bevacizumab 2019 2022
Herceptin Transtuzumab 2019 2014
Humira Adalimumab 2016 2018
Synagis Palivizumab 2015 2015
NON HUMANIZED ANTIBODIES
Erbitux Cetuximab 2016 2014
Remicade Infliximab 2018 2015
Rituxan Rituximab 2018 Expired
NON ANTIBODY MOLECULES
Enbrel Etarnacept 2028 2015
Epogen/Epex Epoetin alfa Expired Expired
Neupogen Filgrastin Expired Expired
Lantus Insulin 2014 2014
Levenox Enoxaparin Expired Expired

6. REGULATORY ASPECTS
• Different from Novel Biologics
• Dynamic and complex nature of the global Biosimilars industry
• Lack of a uniform set of standards for approval
Divergent Interest Complex Molecules Uncertain Long Term Impact
EVOLVING GLOBAL REGULATORY ENVIRONMENT
• The First Market, Guidelines In 2005
• Largest biosimilars market in the world
with robust guidelines
• In 2009, Guidelines for Evaluation of Similar
Bio- therapeutic Products
•In 2012, DBT released a guideline for similar
Biologics
• In 2014, FDA released a draft guideline for
similar Biologics
EUROPEAN UNION
(EMEA)
WHO
INDIA-DBT
USA FDA

7. INDIAN SCENARIO
• India is one of the leading
contributors in the world
Biosimilar market (Potential
to replicate success of Indian
Generic Industry)
• In 2000, the first “similar
biologic” was approved and
marketed in India for a hepatitis
B vaccine
• In recent years, over 50
biopharmaceutical products
have been approved for
marketing in India, with
more than half of them being
“similar biologics”.
Product Name Active Substance Therapeutic Areas Company
Alzumab Itolizumab Psorasis Biocon
Basalog Insulin glargine Diabetes Biocon
Biomab EGFR Nimotuzumab Head and Neck
Cancer
Biocon
CanMab Trastuzumab Breast Cancer Biocon
Grafeel Filgrasim Cancer Dr. Reddy’s Lab
Insugen Human Insulin Diabetes Biocon
MabTas Rituximab Lymphoma Intas Pharma
Nufil Filgrastim Cancer Biocon
Filgrastim Filgrastim Cancer Lupin
Peg-filgrastim Pegfilgrastim Cancer Lupin
Peg grafeel Pegfilgrastim Cancer Dr. Reddy’s Lab
Reditux Rituximab Lymphoma Dr. Reddy’s Lab
Relibeta Interferon beta Multiple Sclerosis Reliance Life
Sciences
Religrast Filgrastim Cancer Reliance Life
Sciences
Rituximab Rituximab Non-Hodgkin’s
lymphoma
Zenotech Laboteries

8. INDIAN PLAYERS IN BIOSIMILARS
• Indian companies enjoy lower
facility and development costs
than peers in developed
countries
• Repeat successes achieved in
small molecule generics by
partnering with larger
multinational corporations
(MNCs) for clinical trials,
regulatory approval process in
the EU / US and marketing to
physicians / consumers.

9. BIOSIMILARS INDUSTRY
GROWTH DRIVERS
These Drivers apply in Common to both the Global as well as
the Indian Market

10. BIOSIMILARS IMPORTANCE TO INDIA
BENEFITS TO INDIA
Benefits to Patient Population Commercial/ Industrial Benefits
• India is a Developing country
very few people today have health
insurance.
• Approximately 70% of Indians pay for
health care expenses out of their own
pockets and this is one of the important
causes of poverty in the country
• Making the medication affordable
• Accessible to all sections of Society
• Shorter time to market than
originator products
India has inherited advantages of:
• Cost effective manufacturing
• Highly skilled, reasonably priced
workforce
• Huge market
• Higher probability of Return on
Investment (ROI) than with new product
•For instance, European Generic
Medicines Agency estimated that
biosimilars generated annual savings of
€ ∼ 1.4 billion in EU in 2009
Active Substance Trade Name Company Price (INR)
Insulin Glargine
(100 IU x 1 mL x 10ml)
Lantus Sanofi Aventis 2530
Basalog Biocon 1475

11. CHALLENGES
REGULATORY AND
LEGISLATIVE
CHALLENGES
QUALITY AND
SAFETY
CONSIDERATIONS
COST
CONSIDERATIONS
• Indian produced
Biosimilars do not have
the same credibility as
international competitors
• Reluctance from
physicians to prescribe
and use biosimilars
• Concerns regarding their
efficacy, long-term
safety & immunogenicity
• Regulated Markets:
Strict regulations and
expensive clinical trials,
as well as relatively
new approval
processes
• Semi & Unregulated
Markets: approval
path is unpredictable,
sometimes increasing
costs and process
complexities
• Limited guarantee of
return on investment.
• High Cost for
development
• Time consuming
process (it can take 8-
10 years) and time to
market is very critical
COPYING IS EASY ??

12. REFERENCES
• Formula of success Emerging trends in Biosimilars in India,
IBEF, www.ibef.org
• Guidelines on similar biologics, DBT India, 2012
• An Overview of Biosimilars and the Biosimilar Pathway
in India, Bricwallblog.worldpress.com, 2014