The document discusses strategies for developing biosimilars in a cost-effective manner. It notes that while the biopharmaceutical opportunity is large, biosimilar development faces significant challenges related to regulation, manufacturing complexity, and marketing limitations. Companies therefore pursue various strategies like building internal capabilities, outsourcing non-core functions, partnering, and acquisitions. The document uses Reliance Life Sciences as a case study, outlining its multi-pronged approach to developing an integrated biosimilars pipeline and capabilities through both internal investment and external partnerships and deals.

1. Reviewing Cost Effective Solutions to Support
Your Biosimilars Strategy
CPhI Worldwide Pre-show Conference
Rahul Padhye
Head, Corporate Development
Paris – Oct 4, 2010
1

2. Contents
1. Biosimilar Development Perspective
2. Strategic Aspects
3. Reliance Life Sciences Context
4. Summary
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3. Biopharmaceutical Opportunity
Global Pharmaceutical Industry
2009 Revenues
USD 837 billion
Global pharmaceutical revenues
USD 837 billion Biopharma, 90
Global biopharmaceutical
revenues USD 90 billion
Pharmaceutical growth rate 5-8%
Biopharmaceutical growth rate 12-
15 % Small Molecule,
747
Source: IMS
Biopharmaceuticals contribute to about 11% of
pharmaceutical revenues and is growing at 12-15 % p.a.
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4. Biosimilars Opportunity
US Europe ROW
CAGR
14000 Percent
11,890
12000
10000
+ 57%
47.8
$ Millions
8000
6,411
6000
3,802 53.5
4000
2,434
1,255 1,684
2000
60.4
0
2008 2009 2010 2011 2012 2013
Year
Source: Global Industry Analysts Report (2006), National Coalition on Healthcare, McKinsey
The global biosimilars market potential is substantial.
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5. Biosimilar Development – Competencies
Molecular Process Quality Clinical Regulatory
Manufacture Marketing
Biology Development Management Research Affairs
Target Bioprocess dev Quality control Pre-clinical Dossiers Upstream Product mgmt.
identification Bioanalytical Quality Toxicity studies preparation Downstream Sales
Gene synthesis dev. assurance Efficacy Regulatory Purification Medical affairs
Gene validation Stability Validation studies interface Fill-finish Pharmaco-
Electrophoresis studies Animal models Intellectual Packaging Vigilance
Stable clone Process scale- Bioassays dev. property Bioprocess Market research
Clone up Clinical control
expression Clinical opns.
Project mgmt.
Biometrics
Medical writing
GXP Compliance
An integrated biopharmaceutical initiative requires several
competencies working seamlessly across the value chain.
5

6. Biosimilar Development - Challenges
Technology
Extensive product characterization
required
Manufacturing complexity
High capital costs for setting up large-
scale manufacturing facility
Higher cost to prove comparability
Regulatory
Need clinical trials which are expensive
Regulatory pathway in US is still unclear
Marketing
Limited discounting ability (discounting
in the range 25-30%) so ability to
compete on price
Brand development and promotional
efforts
Biosimilars are a big opportunity; but is capital intensive with
long gestation period.
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7. Biosimilar Development -Competitive Advantages
Quality
Precise sequence
Process development
Bioassay specificity and linearity
Cost
High productivity cell lines
Downstream yields
Scaled-up process, particularly
for antibodies
Timelines
In-house development vs.
outsourcing
Clinical development geography
Competitive advantages of quality, cost and timelines are
derived from skills, technology and development strategy.
7

8. Contents
1. Biosimilar Development Perspective
2. Strategic Aspects
3. Reliance Life Sciences Context
4. Summary
8

9. Competency Gaps
Mol. Biology
Regulatory Quality
Management Process Dev
Affairs
High
Manufacturing
Importance
Clinical
Development Marketing
& sales
Low
Intellectual
Property
Low High
Competency Gap
Competency gaps led biosimilar players to adopt different
strategies for product development and commercialization 9

10. Strategies
Strategies
Build
Outsource
Partner
Acquire
Combination of above
Factors
Track record
Expediency
Risk appetite
Profitability aspirations
Biopharmaceutical company can follow several strategies
for product development.
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11. Outsourcing – Small molecules vs. Biosimilars
Aspect Small Molecules Proteins/MAbs
Product Can outsource product Cell lines are key for biosimilar
development development (chemical product development and
synthesis) to CROs therefore can ideally be
Large no. of CRAM developed in-house.
players provide these Very few CROs provide cell line
services on time and development ability and the fee
materials basis structure involves licensing fees
Manufacturing Can outsource Biosimilars manufacturing is
manufacturing to vertically integrated up to
different manufacturers formulated bulk so one can, at
for drug intermediate, most, outsource fill-finish
bulk drug and formulated operations
drug product
Clinical Easy to outsource Need extensive exercise for
Development clinical trials (BA/BE clinical development , which will
studies) – requires less include pre-clinical studies, Ph 1
time and effort and Ph 3 studies
Outsourcing biosimilars development is difficult compared to
small molecules.
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12. Outsourcing Options
Areas for Outsourcing
Molecular Process Clinical Regulatory
Manufacture Marketing
Biology Development Research Affairs
Outsourcing Potential
Moderate High Moderate to High Low
CRO/CMO CRO CMO CSO
Cell line development Clinical research Process scale-up
Product Regulatory filings Drug substance
characterization mfg.
Process development Fill/finish
Where to Outsource?
US/EU US/EU + US/EU +
Emerging Markets? Emerging Markets?
Emerging markets can provide cost-time advantage for
biosimilars development.
12

13. Strategies
Strategies
Build
Outsource
Partner
Acquire
Combination of above
Factors
Track record
Expediency
Risk appetite
Profitability aspirations
Biopharmaceutical company can follow several strategies
for its product development.
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14. Biosimilars Licensing – Objectives
Licensor:
Non-dilutive funding
Recognition/Validation of product
quality
Opportunity to work with Partner on
additional products/areas
Licensee:
Adding to internal product pipeline
Timing – faster to market compared
to internal development
Better product – higher cell line
productivity
Accessing cost competitive product
development and manufacturing
capabilities
Licensing can help each partner achieve its objectives.
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15. Biosimilar Licensing Deals (1)
Year 2005 2006 2007 2008/2009 2010
Licensor Pliva Stada Biocon Intas Watson
Licensee Mayne Pharma Hospira Abraxis Apotex Itero
Products EPO and GCSF EPO GCSF GCSF, PEG-GCSF FSH
Stada – Germany, Abraxis– NA, UK,
Hospira – NA, EU Germany, Spain,
Pliva – CEE, US
(except Germany) Italy, France (Co- Watson –
and JP; Mayne – Apotex – NA & EU;
Territory (Hospira has the first exclusivity in worldwide
W. Europe, Intas – RoW
right of refusal for all other EU rights
APAC, MENA
countries outside US countries);
and EU) Biocon – RoW
Pliva –
Intas – Watson -
Roles and Manufacturing;
Stada - Complete Manufacturing, Complete
Responsibility Both parties - Not Disclosed
product development Both parties - Co- product
of Parties joint clinical
development development
development
Upfront US$ 21 million US$ 21 Million Not disclosed Not disclosed
US$ 7.5 million
Milestones over 3 years US$ 34 Million Not disclosed Not disclosed
Royalty Not Disclosed Not Disclosed Not disclosed Not disclosed Not disclosed
US$ 21 mn + US$ 7.5 mn +
Total US$ 55 mn + Royalties Not disclosed Not disclosed
Royalties Royalties
Generic pharma companies have done outlicensing deals
for some of the first generation biosimilars (EPO & GCSF).
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16. Biosimilar Licensing Deals (2)
Partners Biocon & Mylan Teva & Lonza Hospira & Celltrion Hikma & Celltrion
Year 2009 2009 2009 2010
Eight Products Nine Products
Products MAbs MAbs
(most likely MAbs) (most likely MAbs)
Mylan – US,
Canada, EU, JP,
AU,NZ, EU-FTA US, EU, Australia,
Territory Global MENA
countries and co- NZ, Canada
exclusivity with
Biocon for ROW
Celltrion would be
Celltrion would be
responsible for
responsible for
Joint manufacturing &
Roles and manufacturing &
Joint development development supply; Hikma to
Responsibility supply; Co-
by both the parties by both the market the
of Parties marketing of
parties products
products by
exclusively under
partners
own brand name
Deal Structure Profit Sharing Joint Venture Alliance Alliance
Partnerships for product pipelines (mostly MAbs) are the
‘flavor of the season’.
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17. Biosimilars Licensing - Strategies
Pipeline deal with one partner
Deal management is simple
No flexibility and high risk if
partner is unable to deliver
Licensing deal with multiple partners
Risk is diversified
Alliance management is difficult
Selective partnering – products /
geographies
Risk is diversified
Deal management complex
Timing
Early stage
Late stage
There is no single strategy for licensing. It depends on the
needs of both partners.
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18. Contents
1. Biosimilar Development Perspective
2. Challenges
3. Strategic Aspects
4. Reliance Life Sciences Context
5. Summary
18

19. Reliance Life Sciences Initiatives
Clinical
Bio- Regenerative Molecular Plant Industrial
Pharmaceuticals Research Biofuels
pharmaceuticals Medicine Medicine Biotechnology Biotechnology
Services
Plasma Pre-clinical Embryonic Molecular Plant Tissue
API Agronomy Biopolymers
Proteins Studies Stem Cells Diagnostics Culture
BA/BE Farm Hematopoietic Plant Metabolic
Biosimilars Formulations Genetics Biochemicals
Studies Advocacy Stem Cells Engineering
Monoclonal Phase 1 Plant Metabolic Ocular Predictive Plant
Antibodies Studies Engineering Stem Cells Diagnostics Products
Phase 2/3/4 Plant Tissue Skin and
Studies Culture Tissue Engg.
Novel Data Mgmt. Cord Blood
Enzymology Repository
Therapeutics & Biostatistics
Trans-
QTc Studies
Esterification
Fusion
Proteins
siRNA
Molecules
Reliance Life Sciences is building one of the most diverse
and integrated life sciences initiatives in the world.
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20. Biosimilars Product Pipeline
Products in Indian market
Erythropoietin (ReliPoietin™)
GCSF (ReliGrast™)
Interferon (ReliFeron™)
Reteplase TPA (MIRel™)
FSH (FostiRel ™)
Products under development
Cytokines
Interferons
Hormones
Monoclonal antibodies
Blood Factors
Reliance Life Sciences is developing and bringing to market a
range of biosimilars.
20

21. Biosimilars Strategy
Build
Entire value chain
Institutionalized competency
development
Outsource/Access
Product characterization
High-expression cell lines
Cell line development
Clinical development in EU
Partner
Clinical development
(inbound)
Contract manufacturing
(inbound and outbound)
RNA Delivery technologies
Acquire
GeneMedix
Reliance Life Sciences has adopted a multi-pronged strategy
in developing an integrated biopharmaceutical play.
21

22. Contents
1. Biosimilar Development Perspective
2. Challenges
3. Strategic Aspects
4. Reliance Life Sciences Context
5. Summary
22

23. Summary
The biopharmaceutical
opportunity is compelling
Challenges are formidable
Strategic considerations and
responses are critical to
developing biosimilars in a
cost-effective manner
Emerging markets can
provide time-cost advantage
for developing biosimilars
Reliance Life Sciences is a
notable example in context
Developing biosimilars in cost-effective manner in emerging
markets is challenging, but is doable.
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24. Thank You
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