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Bharatbook.com has added the special report , which sources information of 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. Reddy’s, 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. Companies Mentioned Sandoz Teva Pharmaceuticals Ltd Hospira Inc Dr. Reddy’s Laboratories Biocon Ltd Biopartners Watson Pharmaceuticals STADA Arzneimittel AG Reliance Life Sciences Intas Biopharmaceuticals Celltrion Inc. 3SBio Inc. 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 FDA’s 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. Reddy’s 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 Pfizer–Biocon Deal 122 9.1.2 Teva Acquired Ratiopharm 122 9.1.3 Watson–Itero Deal 122 9.1.4 Biocon and Mylan Strategic Collaboration 122 9.1.5 Merck Acquired Insmed’s Follow-On Biologics for $130m 122 9.1.6 Teva and Lonza JV Targets Biosimilars 123 9.1.7 GTC Enters Follow-On-Biologic Founder Development Collaboration with Ag Research 123 9.1.8 Apotex–Intas Deal 123 9.1.9 Teva Acquires CoGenesys 123 9.2 R&D Licensing Deals 124 9.2.1 Innogene Seals Deal With CIMAB to Market Biosimilars 124 9.2.2 Abraxis Licenses Rights to Biosimilar from Indian Firm Biocon 124 10 Biosimilars Approval Pathways in the US and Europe – Appendix 125 10.1 Market Definitions 125 10.2 Abbreviations 126 10.3 Research Methodology 128 10.3.1 Coverage 128 10.3.2 Secondary Research 128 10.3.3 Primary Research 129 10.3.4 Expert Panel Validation 129 10.4 Contact Us 129 10.5 Sources 130 10.6 Disclaimer 130 List of Tables Table 1: Biosimilars Approval Pathways in the US and Europe, Medicare Formulary Coverage for Top-Selling Biologics 20 Table 2: Biosimilars Approval Pathways in the US and Europe, Global, Market Forecasts, ($m), 2009–2016 26 Table 3: Biosimilars Approval Pathways in the US and Europe, the US, Market Forecasts, ($m), 2009–2016 28 Table 4: Biosimilars Approval Pathways in the US and Europe, Europe, Market Forecasts, ($m), 2009–2016 29 Table 5: Biosimilars Approval Pathways in the US and Europe, Japan, Market Forecasts, ($m), 2009–2016 30 Table 6: Biosimilars Approval Pathways in the US and Europe, Global, hGH Biosimilars Market Forecasts, ($m), 2009–2016 31 Table 7: Biosimilars Approval Pathways in the US and Europe, Global, EPO Biosimilars Market Forecasts, ($m), 2009–2016 33 Table 8: Biosimilars Approval Pathways in the US and Europe, Global, G-CSF Biosimilars Market Forecasts, ($m), 2009–2016 35 Table 9: Biosimilars Approval Pathways in the US and Europe, Global, Interferon alfa Biosimilar Market Opportunity Analysis, ($m), 2009–2016 37 Table 10: Biosimilars Approval Pathways in the US and Europe, Global, Interferon-beta Biosimilar Market Opportunity Analysis, ($m), 2009–2016 39 Table 11: Biosimilars Approval Pathways in the US and Europe, Global, Insulin and Insulin Analogs Biosimilar Market Opportunity Analysis, ($m), 2009–2016 40 Table 12: Biosimilars Approval Pathways in the US and Europe, Global, TNF alfa Inhibitor Biosimilar Market Opportunity Analysis, ($m), 2009–2016 42 Table 13: Biosimilars Approval Pathways in the US and Europe, Global, Monoclonal Antibodies Against Cancer Biosimilar Market Opportunity Analysis, ($m), 2009–2016 44 Table 14: Biosimilars Approval Pathways in the US and Europe, Cost-Sharing Practices by Health Insurers in the US, 2009 50 Table 15: Biosimilars Approval Pathways in the US and Europe, Comparison for a Biosimilar, 2010 54 Table 16: Biosimilars Approval Pathways in the US and Europe, Patent Expiry for Major Biologic Drugs, 2010–2016 55 Table 17: Biosimilars Approval Pathways in the US and Europe, Costs of Development, Manufacturing and Approval of Biosimilars By Cell Culture Type, ($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 Figures Figure 1: Biosimilars Approval Pathways in the US and Europe, Global Biologics Market Forecast, ($bn), 2007–2016 11 Figure 2: Biosimilars Approval Pathways in the US and Europe, Share of Top 25 Biologics By Therapeutic Class, 2009 12 Figure 3: Biosimilars Approval Pathways in the US and Europe, Growth for Biologics, 2010 13 Figure 4: Biosimilars Approval Pathways in the US and Europe, Share of Top 25 Biologics By Production System, 2008 14 Figure 5: Biosimilars Approval Pathways in the US and Europe, Biologics Under Development by Therapeutic Class, Global, 2008 15 Figure 6: Biosimilars Approval Pathways in the US and Europe, Biologics Under Development by Disease Category, Global, 2008 16 Figure 7: Biosimilars Approval Pathways in the US and Europe, Comparison of Small Molecule Drugs and Biologics 17 Figure 8: Biosimilars Approval Pathways in the US and Europe, Difference Between the Distribution Chains for Small Molecule and Biologic Drugs 18 Figure 9: Biosimilars Approval Pathways in the US and Europe, Medicare Coverage for Biologic Drugs, 2009 19 Figure 10: Biosimilars Approval Pathways in the US and Europe, Imminent Biosimilar Opportunities, 2010 21 Figure 11: Biosimilars Approval Pathways in the US and Europe, Comparison of Biosimilars With Generics, 2010 22 Figure 12: Biosimilars Approval Pathways in the US and Europe, Development Costs and Timelines for a Biosimilar, 2010 23 Figure 13: Biosimilars Approval Pathways in the US and Europe, Challenges and their Solutions in Biopharmaceutical Manufacturing, 2010 24 Figure 14: Biosimilars Approval Pathways in the US and Europe, Global, Market Forecasts, ($m), 2009–2016 26 Figure 15: Biosimilars Approval Pathways in the US and Europe, the US, Market Forecasts, ($m), 2009–2016 27 Figure 16: Biosimilars Approval Pathways in the US and Europe, Europe, Market Forecasts, ($m), 2009–2016 28 Figure 17: Biosimilars Approval Pathways in the US and Europe, Japan, Market Forecasts, ($m), 2009–2016 30 Figure 18: Biosimilars Approval Pathways in the US and Europe, Global, hGH Biosimilars Market Forecasts, ($m), 2009–2016 31 Figure 19: Biosimilars Approval Pathways in the US and Europe, Global, EPO Biosimilars Market Forecasts, ($m), 2009–2016 33 Figure 20: Biosimilars Approval Pathways in the US and Europe, Global, G-CSF Biosimilars Market Forecasts, ($m), 2009–2016 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 For more information kindly visit : http://www.bharatbook.com/detail.asp?id=185839&rt=Biosimilars-Approval-Pathways-in-the-US-and-Europe-Development-and-Approval-of-Biosimilar-mABs-May-Face-Tough-Regulatory-Environment.html Related Reports Global Biosimilars Market Analysis http://www.bharatbook.com/detail.asp?id=202087&rt=Global-Biosimilars-Market-Analysis.html The 2011-2016 Outlook for Biosimilars in Greater China http://www.bharatbook.com/detail.asp?id=187488&rt=The-2011-2016-Outlook-for-Biosimilars-in-Greater-China.html -30- Or Contact us at : Bharat Book Bureau Tel: +91 22 27578668 Fax: +91 22 27579131 Email: info@bharatbook.com Website: www.bharatbook.com Follow us on twitter: http://twitter.com/#!/BharatBook Please visit our blog at http://bharatresearch.wordpress.com
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