The Future of Biosimilars: Key opportunities & emerging therapies

The Future of Biosimilars: Key opportunities & emerging therapies

Biotechnological products are continuing to exhibit substantial revenue gains, with the top 12 biologics registering sales growth of 20%in 2006, amassing a market share of $64 billion. However, the impending patent expiry of many leading products has created a number of highly attractive market opportunities for biosimilars. To exploit this significant potential, a complex route to market must first be negotiated, including numerous barriers to entry and regulatory hurdles. Prominent obstacles include the sizeable investments in time and expertise associated with biosimilars development, in addition to the fundamentally higher levels of cost and risk incurred by manufacturers. Legislative restraints in the US and a recently established regulatory framework in the EU have also contributed to industrial obtrusiveness, but for those developers who persevere, biosimilars are set to offer lucrative returns. The Future of Biosimilars: Key opportunities and emerging therapies is a new report published by Business Insights, examining the current market and regulatory environment for biosimilars in Europe, India, China and the US, whilst identifying the trends that will shape future market development.

Table of Contents
The Future of Biosimilars
Executive Summary 8
Introduction to biosimilars 8
Market landscape for biosimilars: Europe and USA 9
Emerging market landscape for biosimilars: China and India 10
Competitive landscape 10
Case studies 11
Future trends in biosimilars 12
Chapter 1 Introduction to biosimilars 14
Summary 14
Introduction 15
Biosimilars vs generic pharmaceuticals 16
The nomenclature debate 18
Market opportunities 19
Key trends in biosimilar product development 21
Industry profile 23
Challenges faced by biosimilar developers 27
Pre-marketing hurdles 27
Post-marketing challenges 29
Future trends 30
Chapter 2 Market landscape: Europe and
USA 32
Summary 32
Introduction 33
Features of the EU market for biosimilars 33
Regulatory framework 33
Experience with EU framework 35
National laws 36
Drivers and constraints for biosimilars in the EU market 37
Features of the US market for biosimilars 39
Regulatory framework 39
Follow-on biotech drugs 40
Follow-on biologicals 42
Experience with US regulatory mechanisms 42
Drivers and constraints for biosimilars in the US market 44
Chapter 3 Emerging market landscape for
biosimilars: China and India 48
Summary 48
Introduction 49
Features of the Chinese market for biosimilars 50
Regulatory framework 50
Biopharmaceutical market 52
Biopharmaceutical industry 53
Features of the Indian market for biosimilars 57
Regulatory framework 57
Biopharmaceutical industry 58
Conclusion 64
Chapter 4 Competitive landscape 66
Summary 66
Introduction 67
Leading biosimilars players 68
Teva 68
Sandoz 70
Barr/Pliva 72
Biopartners/Bioton 74
Stada/Bioceuticals 76
BioGeneriX/ratiopharm 78
Niche players 79
CoGenesys 79
Maxygen 80
Viropro 81
Trends in the biosimilars industry 82
Chapter 5 Case studies 86
Summary 86
Introduction 87
Sandoz' Omnitrope: a regulatory saga 88
Comparison of EU approval routes for Omnitrope and Valtropin 89
Conclusions 89
Targeting superbiosimilars: Neose Technologies 91
EPO market 92
G-CSF market 94
Conclusions 95
Taking developed products to market: SciGen 96
Manufacturing risks 97
Marketing strategy 98
Pipeline growth 99
Conclusions 100
Chapter 6 Future trends in biosimilars 102
Summary 102
Introduction 103
Main product opportunities 104
Product development issues 106
Pricing trends 106
Market impact of biosimilars 108
Factors affecting biosimilar penetration 109
Interchangeability/substitution policies 109
Product differentiation 110
Marketing strategies 110
Competition 111
Chapter 7 Appendix 112
Primary research methodology 112
Glossary 118
Index 120
List of Figures
Figure 1.1: Product groups most affected by biosimilars by 2010 21
Figure 1.2: Major challenges faced by biosimilar companies 28
Figure 3.3: Markets with highest potential for biosimilar penetration 50
Figure 3.4: Development of Chinese biopharmaceutical market, 2001-2006 53
Figure 4.5: Types of partnerships favored by biosimilar companies 83
Figure 5.6: Global EPO market 92
Figure 5.7: Global G-CSF market 95
Figure 6.8: Price differential between original brand and biosimilar 107
Figure 6.9: Penetration of biosimilars in biotech market by 2010 108
List of Tables
Table 1.1: Sales trends of leading biologics by product category, 2006 20
Table 1.2: Patent status of key categories 22
Table 1.3: Marketed biosimilars by product group 22
Table 1.4: Summary of leading companies' biosimilar projects 25
Table 4.5: Teva's biosimilar products 70
Table 4.6: Stada's geographical sales distribution 76
Table 6.7: Selected target products for biosimilar developers 105