TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
Key findings 4
Key definitions 5

CHAPTER 2 REVIEW OF KEY BIOSIMILAR DEVELOPERS’ PORTFOLIO AND PIPELINE 12
Introduction 12
Future launches are expected to increase the diversity of the biosimilar market 13
Human growth hormone dominates the therapeutic focus of currently-marketed biosimilars 13
Pipeline biosimilars are targeting an increased number of recombinant protein classes 16
Biosimilar developers are turning to a range of drug delivery and formulation technologies to differentiate their products from competitors 18
Innovative injection devices dominate advanced biosimilar drug delivery 19
Improving biosimilar pharmacodynamics using pegylation-like technologies dominates advanced biosimilar drug reformulation 20
Biosimilar developers deprioritize emerging markets and focus pipeline launches on Western markets to maximize profit 22

CHAPTER 3 COLLABORATION AND M&A TRENDS IN THE BIOSIMILARS MARKET 24
There are a wide range of drivers powering licensing and M&A deals 25
Deals are used extensively in the biosimilars market to enable biosimilars to penetrate new markets 27
Top-12 biosimilar developers use M&A deals over licensing deals to access emerging markets 28
Both M&A deals and licensing deals are used by biosimilar developers to access Western markets 29
The core focus for licensing deals is to source marketed and/or pipeline products 29
Much licensing and M&A activity focuses on improving market access or putting up barriers for competitors 30
Biosimilar manufacturers use licensing deals rather than M&A deals to gain access to reformulation and/or drug delivery technologies 30
Deals can also be used to provide a biosimilar with a larger specialist sales force to remove barriers to entry and improve market access 31

CHAPTER 4 BIOSIMILAR COMPANY PROFILES 32
Key biosimilar companies profiled 32
Leading biosimilar developers 33
Teva (and its subsidiary SICOR) 34
Sandoz 38
Barr (through acquisition of Pliva) 45
Stada (through Bioceuticals) 50
BioPartners 55
BioGeneriX (ratiopharm group) 62
New, smaller biosimilar-focused companies 66
Cangene 66
Hospira 71
Phage Biotechnology 74
Dragon Pharmaceutical 80
Neose Technologies 83
GeneMedix 86
Emerging market-based biosimilar developers and very early-stage companies 92
Indian biosimilars players 92
Chinese biosimilars players 99
Very early-stage biosimilars companies 102

CHAPTER 5 BIBLIOGRAPHY 104

CHAPTER 6 APPENDIX : SUPPORTING DATA 109
Definitions 109

LIST OF TABLES
Table 1: Patent expiries of selected key recombinant proteins 15
Table 2: Western M&A targets tend to be more expensive than deals focusing on acquiring emerging market targets 28
Table 3: Teva’s biosimilar product portfolio and pipeline 35
Table 4: Sandoz’ biosimilar product portfolio and pipeline 40
Table 5: Pliva’s biosimilar product portfolio and pipeline 46
Table 6: Stada acquisitions and divestments, 2005-06 51
Table 7: Bioceuticals’ biosimilar product portfolio and pipeline 51
Table 8: BioPartners’ biosimilar product portfolio and pipeline 56
Table 9: BioGeneriX’s biosimilar product portfolio and pipeline 63
Table 10: Cangene’s biosimilar product portfolio and pipeline 68
Table 12: Dragon Pharmaceutical’s biosimilar product portfolio and pipeline 81
Table 13: Superbiosimilar products developed by Neose Technologies 84
Table 14: GeneMedix’s biosimilar product portfolio and pipeline 88
Table 15: Biosimilar products already marketed in India 94
Table 16: Marketed products from Chinese biosimilars manufacturers 100

LIST OF FIGURES
Figure 1: Launched biosimilars belong to six classes of recombinant proteins 13
Figure 2: At least fourteen classes of recombinant proteins are being targeted by biosimilar pipeline drugs in development by the major biosimilar developers 17
Figure 3: Pegylation accounts for the majority of biosimilar modifications made by developers 19
Figure 4: The majority of currently-marketed biosimilars have launched in emerging markets, although the majority of pipeline biosimilars are targeting Western markets 22
Figure 5: Licensing and collaboration deals are used for different purposes compared to M&A deals 25
Figure 6: The focus for licensing and collaboration deals differs from the focus for entering into M&A deals 26
Figure 7: There are three core deal drivers powering both licensing and collaboration deals, and M&A deals 27
Figure 8: Datamonitor expects the initial market leaders to be those with the greatest financial backing and commercial expertise 33
Figure 9: Phage Biotechnology’s biosimilar product portfolio and pipeline 76