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PharmaSphere: Global Biosimilars Strategy - Regulatory Landscape, Key Drivers, Markets and Trends in 2013

Published By :

GlobalData

Published Date : May 2013

Category :

Therapeutic Area

No. of Pages : 152 Pages


PharmaSphere: Global Biosimilars Strategy Regulatory Landscape, Key Drivers, Markets and Trends in 2013

Summary

GlobalDatas "PharmaSphere: Global Biosimilars Strategy Regulatory Landscape, Key Drivers, Markets and Trends in 2013", provides strategic analysis of the global biosimilars industry. It discusses key market trends, regulatory requirements in various markets, recent deals activity and trends, as well as describes the operations strategy of these companies. Furthermore, it includes a geographical segmentation of various markets including the EU and US, as well as emerging markets such as India providing in-depth analysis of these markets regulatory framework, key domestic players and their biosimilar pipelines, and strategic outlook.

Throughout the report, GlobalDatas analysts provide you with expert insight, expanding on each strategy and factor discussed, with the aim of providing you with the tools needed for making informed business decisions.

Key Questions Answered

  • What are the drivers of the global biosimilars industry?
  • Who are the top players involved in the development of biosimilars in the developed markets of Europe and the US, as well as in emerging markets, including India and China?
  • What are the major barriers to entry into the biosimilars industry?
  • What specific strategies are companies utilizing to combat some of the challenges currently facing the development of the global biosimilars industry?
  • What is the current state of biosimilars regulation in the EU, US, Japan, India, China, and South Korea?

Scope

  • The report provides analysis of the key drivers and trends shaping the global biosimilars industry.
  • The report discusses the biosimilar regulatory landscape of various markets including developed markets of the US and EU, as well as emerging markets such as China and India. Furthermore, it identifies key domestic players in the various markets discussed and provides analysis of their strategy, manufacturing capacity, and clinical pipeline.
  • The report contains a special case study on Teva Pharmaceutical Industries biosimilars business, including an in-depth SWOT analysis of the company
  • The report contains expert insights on the corporate strategies of current and prospective players in the global biosimilars industry.

Key Benefits

  • Understand the frameworks under which biosimilars are currently being reviewed and regulated across various developed and emerging markets
  • Identify the key domestic players in various biosimilar markets, including South Korea, Japan and emerging markets such as India and China
  • Understand the key drivers and trends in the global biosimilars industry
  • Analyze and track the strategies that companies are using to enter and/or strengthen their position in the rapidly evolving biosimilars industry, as well as efforts being made by innovator companies like Amgen to protect their market position
  • Use this information as an independent source for your due diligence and transaction strategy
Table of Content

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. Reddys 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 WHOs 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 Pharmas 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. Reddys 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 Governments 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

List of Table


Table 1: Major Biologic Products 19
Table 2: Ongoing Late-Stage Biosimilar Clinical Trials 27
Table 3: Overview of Biosimilars Deals Analyzed in This Report 32
Table 4: Pfenexs JV with Agila Biotech 33
Table 5: Viropro and Oncobiologics Biosimilars Deal 34
Table 6: Samsung Bioepis and Merck Sign Biosimilars Development Agreement 36
Table 7: Synthons Trastuzumab Deal with Amgen and Actavis 38
Table 8: Dr. Reddys and Merck Serono Ink Biosimilars Co-Development Deal 40
Table 9: Biosimilar Evaluation Requirements WHO, South Korea, EU, and Japan 44
Table 10: Hospiras Biosimilars Pipeline 56
Table 11: Actavis Biosimilars Pipeline 59
Table 12: Pfizers Biosimilars Pipeline 60
Table 13: Authorized Biosimilars in the EU 64
Table 14: Sandozs Current Biosimilars Pipeline 69
Table 15: Stada Arzneimittels Current Biosimilars Pipeline 71
Table 16: Gedeon Richters Current Biosimilars Pipeline 73
Table 17: Kyowa Hakko Kirins Late-stage Biologics Pipeline 82
Table 18: JCR Pharmaceuticals Product Pipeline 84
Table 19: Currently Marketed Biosimilars in India 87
Table 20: Guidelines Applicable to the Research, Development and Marketing of Biosimilars in India 92
Table 21: Biocons Current Biologics Product Pipeline 94
Table 22: Dr. Reddys Current Biosimilars Pipeline 96
Table 23: Ranbaxys Current Biosimilars Pipeline 99
Table 24: Reliance Life Sciences Biosimilars Portfolio 100
Table 25: Cipla Combined Annual Manufacturing Capacities 102
Table 26: Some Biosimilars in Development by South Korean Drug Companies 106
Table 27: Deals in the South Korean Biosimilars Industry 108
Table 28: Celltrion Product Pipeline 113
Table 29: Hanwha Chemicals Current Product Pipeline 116
Table 30: LG Life Sciences Current Product Pipeline 119
Table 31: 3SBios Clinical Pipeline 127
Table 32: Teva Pharmaceutical Industries Biosimilar Pipeline 131

List of Chart


Figure 1: Historical Sales of Branded Biologics, 20082012 and Forecast to 2018 21
Figure 2: New Biologics Approvals by the FDA, 20062012 22
Figure 3: Groups of Companies Involved in Biosimilars Development 25
Figure 4: Trend in Deals in the Biosimilars Industry, 20072013 31
Figure 5: FDA-Recommended Stepwise Approach for Biosimilars Development in the US 51
Figure 6: Current Guidelines on Biosimilars Regulation in the EU 66
Figure 7: Novartis Capabilities being Leveraged by Sandoz 70
Figure 8: Public-Debt and Budget-Deficit-to-GDP Ratios in the Eurozone, 2012 74
Figure 9: PMDAs Current Organizational Chart 77
Figure 10: Review Process for Biosimilars in Japan 78
Figure 11: Indian Regulatory Pathway for Indigenously Manufactured Biologics 89
Figure 12: Indian Regulatory Pathway for Imported Biologics 90
Figure 13: South Koreans Three-tiered Regulatory System for Biosimilars 109
Figure 14: Celltrion Product Pipeline by Therapeutic Area 114
Figure 15: LG Life Sciences R&D Investment, 20092013 (Estimated) 119
Figure 16: Total and Government Healthcare Expenditures* in China, 20012011 122
Figure 17: Application and Approval Procedure for Pharmaceuticals in China 124
Figure 18: Tevas Global Biosimilars Operation: A Recipe for Success 131
Figure 19: Teva Generics Sales in US vs. Rest-of-World (ROW), 20092012 135
Figure 20: Teva Pharmaceuticals: SWOT Analysis 136
Figure 21: Capabilities Needed for Biosimilars Development 139
Figure 22: US Healthcare Expenditure and GDP, 20012010 141

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