PharmaSphere: Global Biosimilars Strategy – Regulatory Landscape, Key Drivers, Markets and Trends in 2013...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 12
1.2 List of Figures 14
2 Introduction 15
2.1 Report Scope 15
2.2 Upcoming Related Reports 16
2.3 Recently Published Reports 17
3 Generics Industry Dynamics 18
3.1 Biologics: An Expensive Necessity 18
3.2 Historical Branded Biologic Sales and Forecast 20
3.3 A Trickling Biologics Pipeline 22
3.4 Why Biosimilars? 23
3.4.1 Rising Healthcare Expenditures 23
3.4.2 The Need to Broaden Healthcare Coverage and Drive Macroeconomic Growth 23
3.5 Biosimilars: Not an ‘Easy’ Venture 24
3.5.1 Complex Manufacturing Processes 24
3.5.2 Rigorous Regulatory Requirements 26
3.5.3 Non-automatic Substitution 26
3.6 Clinical Trials Landscape 27
4 Biosimilar Deals Trends 30
4.1 Highlighted Deals 32
4.1.1 Pfenex Forms JV with Agila Biotech 33
4.1.2 Viropro and Oncobiologics Sign Emerging Markets Biosimilars Deal 34
4.1.3 Samsung Bioepis and Merck Enter Biosimilars Development Agreement 36
4.1.4 Synthon Inks Trastuzumab Licensing Agreement with Amgen and Actavis 38
4.1.5 Dr. Reddy’s and Merck Serono Ink Biosimilars Co-Development Agreement 40
4.2 Additional Deals 42
5 Biosimilars Regulation 43
5.1 Biosimilars: Different Names, Common Themes 43
5.2 WHO’s Guidance on SBPs 43
6 Biosimilars in the US 46
6.1 Overview 46
6.2 The US’ Evolving Regulatory Framework for Biosimilars 47
6.2.1 Big Pharma’s Adverse Reaction to Section 505(b)(2) 47
6.2.2 The Patient Protection and Affordable Care Act 49
6.2.3 Recent Guidances on Biosimilars by the FDA 50
6.3 Mixed Feelings among Stakeholders as US States Embrace Biosimilar Substitution 53
6.4 Key Market Players 54
6.4.1 Hospira 54
6.4.2 Actavis, Inc. 57
6.4.3 Pfizer 59
6.5 Biosimilars in the US: Market Outlook 61
6.5.1 Recent Efforts to Establish a Regulatory Framework for Biosimilars Favors the Development of the Industry 61
6.5.2 Increasing Healthcare Expenditures Will Drive Biosimilars Substitution 61
6.5.3 Large Biotech and Pharmaceutical Companies Will Aggressively Defend their US Market Share 62
6.5.4 Imminent Expiration of Patents to Blockbuster Biologics Will Encourage Biosimilar Developers 62
7 Biosimilars in Europe 63
7.1 Overview 63
7.2 EU-Approved Biosimilars 63
7.3 Guidelines for Biosimilars Development in the EU 65
7.3.1 Omnitrope Triggered the Development of Guidelines for Biosimilars in Europe 65
7.3.2 Applicable Guidance Documents on Biosimilars in Europe 66
7.3.3 Non-Clinical Data and Clinical Studies 67
7.4 Key Market Players 68
7.4.1 Sandoz 68
7.4.2 Stada Arzneimittel 70
7.4.3 Gedeon Richter 72
7.5 Biosimilars in Europe: Market Outlook 74
7.5.1 Financial Austerity Measures Will Further Drive the Uptake of Biosimilars 74
7.5.2 Companies Will Use the EU Market as a Springboard into the US Biosimilars Market 75
8 Biosimilars in Japan 76
8.1 Overview 76
8.2 Regulatory Framework 76
8.2.1 Organizational Structure 76
8.2.2 Biosimilars Review Process 78
8.2.3 Regulatory Guidelines 79
8.3 Key Market Players 80
8.3.1 Kyowa Hakko Kirin Co. Ltd. 80
8.3.2 JCR Pharmaceuticals 83
8.4 Biosimilars in Japan: Market Outlook 85
8.4.1 Cost Containment Measures Will Drive Biosimilars Development 85
8.4.2 CMOs Will Leverage Existing Capabilities to Enter Biosimilars Space 85
9 Biosimilars in India 86
9.1 Gradual Transition from a Semi-Regulated to a Regulated Market 86
9.2 Marketed Biosimilars in India 86
9.3 Regulatory Framework for Biosimilars in India 88
9.3.1 Guidelines on Similar Biologics, 2012 91
9.4 Key Market Players 92
9.4.1 Biocon 92
9.4.2 Dr. Reddy’s Laboratories 95
9.4.3 Ranbaxy Laboratories 97
9.4.4 Reliance Life Sciences 99
9.4.5 Cipla 101
9.5 India Biosimilars Market Outlook 103
9.5.1 Recent Biosimilar Guidelines Will Not Automatically Result in Approval by the EMA and FDA 103
9.5.2 Current Capabilities in Generics Will Increasingly Encourage Participation in Biosimilars Development 103
9.5.3 EU-India Free Trade Agreement Could Open Up Access to the European Market 104
10 Biosimilars in South Korea 105
10.1 Overview 105
10.2 Government Initiatives Aiding the Development of Biosimilars 106
10.3 Joint Ventures and Collaborations Enable Leveraging of Capabilities 108
10.4 Lack of Biologics’ Market Exclusivity Reduces Time-to-Market 108
10.5 Regulatory Framework for Biosimilars 109
10.5.1 Extrapolation of Indications 110
10.6 Key Market Players 111
10.6.1 Celltrion 111
10.6.2 Hanwha Chemical 115
10.6.3 Samsung Bioepis 117
10.6.4 LG Life Sciences 117
10.7 Biosimilars in South Korea: Market Outlook 120
10.7.1 Government’s Initiatives Look Poised to Spur the Local Biosimilars Industry 120
10.7.2 Budding Pipeline Signals Boom for the Biosimilars Industry 120
11 Biosimilars in China 121
11.1 Overview 121
11.1.1 Soaring Healthcare Expenditures Drive Need for Cheaper Therapeutics in China 121
11.1.2 Biosimilars and Reimbursement 122
11.1.3 An IP Loophole 123
11.2 Regulatory Framework for Biosimilars in China 123
11.3 Key Market Players 125
11.3.1 3SBio 125
11.3.2 Shandong Kexing Bioproducts 128
11.4 Biosimilars in China: Market Outlook 128
11.4.1 Ongoing Reform Will Boost Biosimilars Industry 128
11.4.2 Increase in Healthcare Access Bodes Well for Biosimilars in China 129
11.4.3 Collaborative Agreements between Multinationals and Domestic Companies Will Continue 129
12 Case Study: Teva Pharmaceutical Industries 130
12.1 Business Overview 130
12.2 Biosimilars at Teva 130
12.3 Product Portfolio/Pipeline 131
12.4 Company SWOT Analysis 132
12.4.1 Strengths 132
12.4.2 Weaknesses 133
12.4.3 Opportunities 134
12.4.4 Threats 135
13 Strategic Outlook 137
13.1 Patent Expiries Will Continually Fuel Biosimilars Development 137
13.2 Flurry of Regulatory and Legislative Activities Bodes Well for Biosimilars 137
13.3 Extensive Capabilities Needed Will Serve as a Barrier to Entry in the Near to Mid-term 138
13.4 EU-India FTA Will Significantly Benefit European and Indian Biosimilars Companies 139
13.5 Cost-containment Measures Are Expected to Drive Biosimilars Substitution 140
14 Appendix 142
14.1 Bibliography 142
14.2 Abbreviations 146
14.3 Research Methodology 149
14.3.1 Coverage 149
14.3.2 Secondary Research 149
14.3.3 Expert Panel Validation 150
14.4 About the Authors 150
14.4.1 Analyst 150
14.4.2 Director of Healthcare Industry Dynamics 150
14.4.3 Global Head of Healthcare Research and Consulting 151
14.5 About the Industry Dynamics Team 151
14.6 About GlobalData 151
14.7 Contact Us 151
14.8 Disclosure Information 152
14.9 Disclaimer 152