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Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment

Published By :

GBI Research

Published Date : Apr 2011

Category :

Biotechnology

No. of Pages : 130 Pages


GBI Research, the leading business intelligence provider, has released its latest report, Biosimilars Approval Pathways in the US and Europe Development and Approval of Biosimilar mAbs May Face Tough Regulatory Environment that provides key data, information and analysis of the major trends and issues affecting the global biosimilar market. 

The report provides a comprehensive insight into the biosimilar market. It offers geography-wise as well as category-wise market forecasts for biosimilars and provides the drivers and restraints affecting the biosimilars market. The report also talks about the business environment and the key success factors in the global biosimilar industry. 

The report also describes the regulatory environment in the US, top five European markets and Japan with respect to biosimilars. At the end, the report looks into the competitive landscape of the biosimilar industry by offering profiles of key players in the industry and the analysis of major deals that took place in the industry.

Scope

The report covers - 

  • Data and analysis on the biosimilar market in the leading geographies of the world the US, the UK, Germany, France, Italy, Spain, and Japan.
  • Market forecast for global biosimilar market from 2009 to 2016, geography-wise as well as product category-wise.
  • Key drivers and restraints that have had a significant impact on the market globally as well as at national level.
  • The regulatory environment for biosimilars in the US, the EU and in Japan.
  • Analysis of competitive environment in the industry, profiles of key players in the biosimilar market. The companies studied in this report are Sandoz, Teva Pharmaceuticals, Hospira, Dr. Reddys, Biocon, Watson Pharmaceuticals, Biopartners, Reliance Life Sciences, Stada, Intas, Celltrion and 3S Bio.
  • Key M&A activities and Licensing Agreements that took place between 2008 and 2010 in the global biosimilar market.
Reasons to buy

The report will enhance your decision making capability in a more rapid and time sensitive manner. It will allow you to - 

  • Make more informed business decisions from the insightful and in-depth analysis of the global biosimilar market and the factors shaping it.
  • Identify the key areas of deal making through thorough understanding of the deals landscape in the global biosimilar market.
  • Build effective strategies to launch the pipeline products by identifying potential geographies.
  • Identify the companies from emerging nations for collaborations along with their key capabilities.
  • Exploit in-licensing and out-licensing opportunities by identifying products that might fill your portfolio gaps.
Table of Contents

1 Table of Contents

1 Table of Contents 3
1.1 List of Tables 6
1.2 List of Figures 7

2 Biosimilars Approval Pathways in the US and Europe Introduction 10
2.1 GBI Research Report Guidance 10

3 Biosimilars Approval Pathways in the US and Europe Market Overview 11
3.1 Overview of the Biopharmaceutical Industry 11
3.2 Biosimilars and their Significance 19
3.3 Comparison of Biosimilars with Generics 22
3.4 Biopharmaceutical Manufacturing Process 24

4 Biosimilars Approval Pathways in the US and Europe Market Characterization 26
4.1 Global Biosimilar Market Size and Forecast 26
4.2 The US Biosimilars Market Size and Forecast 27
4.3 Europe Biosimilar Market Size and Forecast 28
4.4 Japan Biosimilars Market Size and Forecasts 30
4.5 Market Forecasts for Biosimilars 31
4.5.1 Human Growth Hormone (hGH) Biosimilars Markets 31
4.5.2 Erythropoietin (EPO) Biosimilars Markets 33
4.5.3 Granulocyte Colony Stimulating Factor (G-CSF) Biosimilars Markets 35
4.6 Opportunity Analysis 37
4.6.1 Interferon alfa Biosimilars 37
4.6.2 Interferon beta Biosimilars 38
4.6.3 Insulin and Insulin Analogs Biosimilars 40
4.6.4 TNF alfa Inhibitor Biosimilars 42
4.6.5 Biosimilars for Monoclonal Antibodies against Cancer 43

5 Biosimilars Approval Pathways in the US and Europe Industry Dynamics 45
5.1 Key Success Factors in the Biosimilar Industry 45
5.1.1 Long Term Strategy 45
5.1.2 Sound Financial Structure 46
5.1.3 Comprehensive Competitive Intelligence 46
5.1.4 Biomanufacturing Competencies 46
5.1.5 Clinical Development and Regulatory Expertise 46
5.1.6 Marketing, Sales and Distribution Capabilities 46
5.2 Participants in the Biosimilar Industry 47
5.3 Suppliers 48
5.3.1 Clinical Trial Capability Providers 48
5.3.2 Manufacturing Capacity Providers 48
5.3.3 Media and Reagents Providers 48
5.4 Innovators 49
5.5 Stakeholders 49
5.5.1 Regulators 49
5.5.2 Payers 49
5.5.3 Physicians 50
5.5.4 Patients and Patient Groups 50

6 Biosimilars Approval Pathways in the US and Europe Drivers and Restraints 51
6.1 Drivers 52
6.1.1 Need to Cut Healthcare Costs in Developed Economies 52
6.1.2 Lower Development Costs and Regulatory Costs Compared to a New Biologic Drug 54
6.1.3 Lower Overall Cost of Treatment Using Biosimilar Drugs Compared to Biologics 55
6.1.4 Patent Expiry for Blockbuster Biologics 55
6.1.5 Increasing Uptake of Biologic Drugs 56
6.1.6 More Profitable than Generic Drugs 56
6.2 Restraints 56
6.2.1 Absence of Automatic Substitution 56
6.2.2 Higher Development and Manufacturing Costs Compared to Generics 57
6.2.3 High Entry Barriers 58
6.2.4 Threat from Second Generation Biologic Drugs 58
6.2.5 Patent Protection Around Biologic Drugs 58

7 Biosimilars Approval Pathways in the US and Europe Regulatory Landscape 59
7.1 Regulatory Landscape in the US 60
7.1.1 Regulatory Framework for Biopharmaceutical Industry 60
7.1.2 Evolution of Regulatory Pathways for Biosimilars 62
7.1.3 BPCIA and the Pathway for Approval of Biosimilar Products 65
7.2 FDAs Public Meeting on Biosimilars 70
7.2.1 Data requirement to Demonstrate Biosimilarity 71
7.2.2 The Standard for Interchangeability 71
7.2.3 Naming for Biosimilars 71
7.2.4 Extrapolation 71
7.2.5 Foreign Studies 71
7.2.6 Other Issues 71
7.2.7 Drivers and Barriers 72
7.3 Regulatory Landscape in Europe 73
7.3.1 Regulatory Framework for Biopharmaceutical Industry 73
7.3.2 Evolution of Regulatory Pathways for Biosimilars 74
7.3.3 Current Position on Biosimilars 75
7.3.4 The Bolar Type Provision 80
7.3.5 The Comparability Exercise 81
7.3.6 Biosimilars Approvals and Applications 82
7.3.7 EMEA Guidelines for Biosimilar mAb 84
7.3.8 Issues Facing the European Biosimilars Industry 84
7.3.9 Drivers for the European Biosimilars Market 85
7.3.10 Barriers for the European Biosimilars Market 86
7.3.11 Country Analysis The UK 87
7.3.12 Country Analysis Germany 88
7.3.13 Country Analysis France 90
7.3.14 Country Analysis Spain 91
7.3.15 Country Analysis Italy 93
7.4 Regulatory Landscape in Japan 94
7.4.1 Regulatory Framework for Biopharmaceutical Industry 94
7.4.2 Evolution of Regulatory Pathways for Biosimilars 94
7.4.3 Current Position on Biosimilars 95
7.4.4 Drivers and Barriers 96

8 Biosimilars Approval Pathways in the US and Europe Competitive Landscape 97
8.1 Profiles of Major Biosimilar Players 97
8.1.1 Sandoz 97
8.1.2 Teva Pharmaceuticals Ltd 100
8.1.3 Hospira Inc 102
8.1.4 Dr. Reddys Laboratories 104
8.1.5 Biocon Ltd 106
8.1.6 Biopartners 108
8.1.7 Watson Pharmaceuticals 110
8.1.8 STADA Arzneimittel AG 112
8.1.9 Reliance Life Sciences 114
8.1.10 Intas Biopharmaceuticals 116
8.1.11 Celltrion Inc. 118
8.1.12 3SBio Inc. 120

9 Biosimilars Approval Pathways in the US and Europe Strategic Consolidations 122
9.1 M&A Deals 122
9.1.1 PfizerBiocon Deal 122
9.1.2 Teva Acquired Ratiopharm 122
9.1.3 WatsonItero Deal 122
9.1.4 Biocon and Mylan Strategic Collaboration 122
9.1.5 Merck Acquired Insmeds Follow-On Biologics for $130m 122
9.1.6 Teva and Lonza JV Targets Biosimilars 123
9.1.7 GTC Enters Follow-On-Biologic Founder Development Collaboration with Ag Research 123
9.1.8 ApotexIntas Deal 123
9.1.9 Teva Acquires CoGenesys 123
9.2 R&D Licensing Deals 124
9.2.1 Innogene Seals Deal With CIMAB to Market Biosimilars 124
9.2.2 Abraxis Licenses Rights to Biosimilar from Indian Firm Biocon 124

10 Biosimilars Approval Pathways in the US and Europe Appendix 125
10.1 Market Definitions 125
10.2 Abbreviations 126
10.3 Research Methodology 128
10.3.1 Coverage 128
10.3.2 Secondary Research 128
10.3.3 Primary Research 129
10.3.4 Expert Panel Validation 129
10.4 Contact Us 129
10.5 Sources 130
10.6 Disclaimer 130

List of Table


Table 1: Biosimilars Approval Pathways in the US and Europe, Medicare Formulary Coverage for Top-Selling Biologics 20
Table 2: Biosimilars Approval Pathways in the US and Europe, Global, Market Forecasts, ($m), 20092016 26
Table 3: Biosimilars Approval Pathways in the US and Europe, the US, Market Forecasts, ($m), 20092016 28
Table 4: Biosimilars Approval Pathways in the US and Europe, Europe, Market Forecasts, ($m), 20092016 29
Table 5: Biosimilars Approval Pathways in the US and Europe, Japan, Market Forecasts, ($m), 20092016 30
Table 6: Biosimilars Approval Pathways in the US and Europe, Global, hGH Biosimilars Market Forecasts, ($m), 20092016 31
Table 7: Biosimilars Approval Pathways in the US and Europe, Global, EPO Biosimilars Market Forecasts, ($m), 20092016 33
Table 8: Biosimilars Approval Pathways in the US and Europe, Global, G-CSF Biosimilars Market Forecasts, ($m), 20092016 35
Table 9: Biosimilars Approval Pathways in the US and Europe, Global, Interferon alfa Biosimilar Market Opportunity Analysis, ($m), 20092016 37
Table 10: Biosimilars Approval Pathways in the US and Europe, Global, Interferon-beta Biosimilar Market Opportunity Analysis, ($m), 20092016 39
Table 11: Biosimilars Approval Pathways in the US and Europe, Global, Insulin and Insulin Analogs Biosimilar Market Opportunity Analysis, ($m), 20092016 40
Table 12: Biosimilars Approval Pathways in the US and Europe, Global, TNF alfa Inhibitor Biosimilar Market Opportunity Analysis, ($m), 20092016 42
Table 13: Biosimilars Approval Pathways in the US and Europe, Global, Monoclonal Antibodies Against Cancer Biosimilar Market Opportunity Analysis, ($m), 20092016 44
Table 14: Biosimilars Approval Pathways in the US and Europe, Cost-Sharing Practices by Health Insurers in the US, 2009 50
Table 15: Biosimilars Approval Pathways in the US and Europe, Comparison for a Biosimilar, 2010 54
Table 16: Biosimilars Approval Pathways in the US and Europe, Patent Expiry for Major Biologic Drugs, 20102016 55
Table 17: Biosimilars Approval Pathways in the US and Europe, Costs of Development, Manufacturing and Approval of Biosimilars By Cell Culture Type, ($m), 2010 57
Table 18: Biosimilars Approval Pathways in the US and Europe, Europe, Existing Guidelines for Biosimilars, 2010 75
Table 19: Biosimilars Approval Pathways in the US and Europe, Biosimilar Approvals, 2010 82
Table 20: Biosimilars Approval Pathways in the US and Europe, Europe, Applications Rejected or Withdrawn, 2010 83

List of Chart


Figure 1: Biosimilars Approval Pathways in the US and Europe, Global Biologics Market Forecast, ($bn), 20072016 11
Figure 2: Biosimilars Approval Pathways in the US and Europe, Share of Top 25 Biologics By Therapeutic Class, 2009 12
Figure 3: Biosimilars Approval Pathways in the US and Europe, Growth for Biologics, 2010 13
Figure 4: Biosimilars Approval Pathways in the US and Europe, Share of Top 25 Biologics By Production System, 2008 14
Figure 5: Biosimilars Approval Pathways in the US and Europe, Biologics Under Development by Therapeutic Class, Global, 2008 15
Figure 6: Biosimilars Approval Pathways in the US and Europe, Biologics Under Development by Disease Category, Global, 2008 16
Figure 7: Biosimilars Approval Pathways in the US and Europe, Comparison of Small Molecule Drugs and Biologics 17
Figure 8: Biosimilars Approval Pathways in the US and Europe, Difference Between the Distribution Chains for Small Molecule and Biologic Drugs 18
Figure 9: Biosimilars Approval Pathways in the US and Europe, Medicare Coverage for Biologic Drugs, 2009 19
Figure 10: Biosimilars Approval Pathways in the US and Europe, Imminent Biosimilar Opportunities, 2010 21
Figure 11: Biosimilars Approval Pathways in the US and Europe, Comparison of Biosimilars With Generics, 2010 22
Figure 12: Biosimilars Approval Pathways in the US and Europe, Development Costs and Timelines for a Biosimilar, 2010 23
Figure 13: Biosimilars Approval Pathways in the US and Europe, Challenges and their Solutions in Biopharmaceutical Manufacturing, 2010 24
Figure 14: Biosimilars Approval Pathways in the US and Europe, Global, Market Forecasts, ($m), 20092016 26
Figure 15: Biosimilars Approval Pathways in the US and Europe, the US, Market Forecasts, ($m), 20092016 27
Figure 16: Biosimilars Approval Pathways in the US and Europe, Europe, Market Forecasts, ($m), 20092016 28
Figure 17: Biosimilars Approval Pathways in the US and Europe, Japan, Market Forecasts, ($m), 20092016 30
Figure 18: Biosimilars Approval Pathways in the US and Europe, Global, hGH Biosimilars Market Forecasts, ($m), 20092016 31
Figure 19: Biosimilars Approval Pathways in the US and Europe, Global, EPO Biosimilars Market Forecasts, ($m), 20092016 33
Figure 20: Biosimilars Approval Pathways in the US and Europe, Global, G-CSF Biosimilars Market Forecasts, ($m), 20092016 35
Figure 21: Biosimilars Approval Pathways in the US and Europe, Global, Interferon alfa Biosimilar Market Opportunity Analysis, ($m), 20092016 37
Figure 22: Biosimilars Approval Pathways in the US and Europe, Global, Interferon beta Biosimilar Market Opportunity Analysis, ($m), 20092016 38
Figure 23: Biosimilars Approval Pathways in the US and Europe, Global, Insulin and Insulin Analogs Biosimilar Market Opportunity Analysis, ($m), 20092016 40
Figure 24: Biosimilars Approval Pathways in the US and Europe, Global, TNF alfa Inhibitor Biosimilar Market Opportunity Analysis,($m), 20092016 42
Figure 25: Biosimilars Approval Pathways in the US and Europe, Global, Monoclonal Antibodies Against Cancer Biosimilar Market Opportunity Analysis, ($m), 20092016 43
Figure 26: Biosimilars Approval Pathways in the US and Europe, Global, Expected Market Split in 2016 44
Figure 27: Biosimilars Approval Pathways in the US and Europe, Key Success Factors in the Biosimilar Industry, 2010 45
Figure 28: Biosimilars Approval Pathways in the US and Europe, Comparison of Capabilities of Market Entrants, 2010 47
Figure 29: Biosimilars Approval Pathways in the US and Europe, Drivers and Restraints, 2010 51
Figure 30: Biosimilars Approval Pathways in the US and Europe, Rising Expenditure on Pharmaceuticals, 2010 52
Figure 31: Biosimilars Approval Pathways in the US and Europe, Increase in Elderly Population Indicates Rising Healthcare Expenses, 2010 53
Figure 32: Biosimilars Approval Pathways in the US and Europe, Inflation in Prescription Drug Prices in the US , 2010 54
Figure 33: Biosimilars Approval Pathways in the US and Europe, Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type, ($m), 2010 57
Figure 34: Biosimilars Approval Pathways in the US and Europe, Objectives of Biosimilar Legislation and Regulatory Frameworks, 2010 59
Figure 35: Biosimilars Approval Pathways in the US and Europe, the US, Regulatory Bodies for Biologics, 2010 60
Figure 36: Biosimilars Approval Pathways in the US and Europe, Drug Development and Approval Process, 2010 61
Figure 37: Biosimilars Approval Pathways in the US and Europe, the US, Evolution of Regulatory Pathway, 2010 62
Figure 38: Biosimilars Approval Pathways in the US and Europe, the US, Impact of Data Exclusivity Period on Biosimilars Development, 2010 63
Figure 39: Biosimilars Approval Pathways in the US and Europe, the US, Patent Litigation Provisions in BPCIA Round 1, 2010 66
Figure 40: Biosimilars Approval Pathways in the US and Europe, the US, Patent Litigation Provisions in BPCIA Round 2, 2010 68
Figure 41: Biosimilars Approval Pathways in the US and Europe, Key Issues Discussed at FDAs Public Hearing on Biosimilars, 2010 70
Figure 42: Biosimilars Approval Pathways in the US and Europe, the US, Drivers and Barriers for the Biosimilars Market, 20092016 72
Figure 43: Biosimilars Approval Pathways in the US and Europe, Europe, Drug Approval Process, 2010 73
Figure 44: Biosimilars Approval Pathways in the US and Europe, Europe, Evolution of Regulatory Pathway for Approval of Biosimilars, 2010 74
Figure 45: Biosimilars Approval Pathways in the US and Europe, Europe, General and Product Specific Guidelines for Biosimilars, 2010 77
Figure 46: Biosimilars Approval Pathways in the US and Europe, Europe, Approval Process for Biosimilars, 2010 78
Figure 47: Biosimilars Approval Pathways in the US and Europe, Europe, Data and Market Exclusivity Periods, 2010 79
Figure 48: Biosimilars Approval Pathways in the US and Europe, Europe, Comparability Exercises, 2010 81
Figure 49: Biosimilars Approval Pathways in the US and Europe, Europe, Number of Biosimilar Applications, 20042009 83
Figure 50: Biosimilars Approval Pathways in the US and Europe, Europe, Key Issues Facing Biosimilars Market, 2010 84
Figure 51: Biosimilars Approval Pathways in the US and Europe, Europe, Drivers and Barriers for the Biosimilars Market, 20092016 85
Figure 52: Biosimilars Approval Pathways in the US and Europe, the UK, Drivers and Barriers for the Biosimilars Market, 20092016 88
Figure 53: Biosimilars Approval Pathways in the US and Europe, Germany, Drivers and Barriers for the Biosimilars Market, 20092016 89
Figure 54: Biosimilars Approval Pathways in the US and Europe, France, Drivers and Barriers for the Biosimilars Market, 20092016 91
Figure 55: Biosimilars Approval Pathways in the US and Europe, Spain, Drivers and Barriers for the Biosimilars Market, 20092016 92
Figure 56: Biosimilars Approval Pathways in the US and Europe, Italy, Drivers and Barriers for the Biosimilars Market, 20092016 93
Figure 57: Biosimilars Approval Pathways in the US and Europe, Japan, Evolution of Regulatory Pathway, November 2009 95
Figure 58: Biosimilars Approval Pathways in the US and Europe, Japan, Drivers and Barriers for the Biosimilars Market, 20092016 96
Figure 59: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Sandoz, 2010 97
Figure 60: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Sandoz, SWOT, 2010 99
Figure 61: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Teva, 2010 100
Figure 62: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Teva, SWOT, 2010 101
Figure 63: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Hospira Inc, 2010 102
Figure 64: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Hospira, SWOT, 2010 103
Figure 65: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Dr. Reddys Laboratories, 2010 104
Figure 66: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Dr. Reddys Laboratories, SWOT, 2010 105
Figure 67: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biocon, 2010 106
Figure 68: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biocon, SWOT, 2010 107
Figure 69: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biopartners, 2010 108
Figure 70: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biopartners, SWOT, 2010 109
Figure 71: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Watson Pharmaceuticals, 2010 110
Figure 72: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Watson Pharmaceuticals, SWOT, 2010 111
Figure 73: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, STADA Arzneimittel AG, 2010 112
Figure 74: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, STADA Arzneimittel AG, SWOT, 2010 113
Figure 75: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Reliance Life Sciences, 2010 114
Figure 76: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Reliance Life Sciences, SWOT, 2010 115
Figure 77: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Intas Biopharmaceuticals, 2010 116
Figure 78: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Intas Biopharmaceuticals, SWOT, 2010 117
Figure 79: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Celltrion Inc, 2010 118
Figure 80: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Celltrion Inc, SWOT, 2010 119
Figure 81: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, 3SBio Inc, 2010 120
Figure 82: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, 3SBio Inc, SWOT, 2010 121

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