PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market

Summary

GlobalData’s report, "PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market", 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, GlobalData’s 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.

Highlights

About the Report

GlobalData’s PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market report is an essential source of information and analysis on the global biosimilars industry. Using detailed company data, financial analysis, corporate strategy, and market trends analysis, GlobalData provides in-depth analysis of the current and future growth drivers of the biosimilars industry. The report discusses the various regulatory frameworks under which biosimilars are currently reviewed and regulated. Furthermore, it discusses the key factors shaping and driving the biosimilars business, and provides insights on the competitive landscape and emerging strategies expected to significantly influence the market positions of companies currently involved in the development and commercialization of biosimilars.

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 expert insights on the corporate strategies of current and prospective players in the global biosimilars industry.
- The report contains a special case study on Teva Pharmaceutical Industries’ biosimilars business, including an in-depth SWOT analysis of the company.

Reasons to buy

- 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 Contents

1 Table of Contents

2 Introduction 15
2.1 Report Scope 15
2.2 Upcoming Related Reports 16
2.3 Recently Published Reports 17
3 Market Overview 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? 22
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 23
3.5.1 Complex Manufacturing Processes 24
3.5.2 Rigorous Regulatory Requirements 25
3.5.3 No Automatic Substitution 26
3.6 Clinical Trials Landscape 26
4 Biosimilar Deals Trends 31
4.1 Highlighted Deals 32
4.1.1 Baxter International and Coherus Biosciences Announce Biosimilars Collaboration 35
4.1.2 Genor BioPharma and BioCND Form mAb Partnership for International Markets 37
4.1.3 Pfenex Forms JV with Agila Biotech 38
4.1.4 Viropro and Oncobiologics Sign Emerging Markets Biosimilars Deal 39
4.1.5 Samsung Bioepis and Merck Expand Biosimilars Development Agreement 41
4.2 Additional Deals 44
5 Biosimilars Regulation 45
5.1 Biosimilars: Different Names, Common Themes 45
5.2 WHO’s Guidance on SBPs 45
6 Biosimilars in the US 47
6.1 Overview 47
6.2 The US’ Evolving Regulatory Framework for Biosimilars 47
6.2.1 Big Pharma’s Adverse Reaction to Section 505(b)(2) 48
6.2.2 The Patient Protection and Affordable Care Act 50
6.2.3 Recent Guidances on Biosimilars by the FDA 51
6.3 Mixed Feelings among Stakeholders as US States Embrace Biosimilar Substitution 55
6.4 Key Players and Pipelines 56
6.4.1 Hospira 56
6.4.2 Actavis 60
6.4.3 Pfizer 62
6.5 Biosimilars in the US: Market Outlook 64
6.5.1 Efforts to Establish a Regulatory Framework Favors the Development of the Industry 64
6.5.2 Increasing Healthcare Expenditures Will Drive Biosimilars Substitution 65
6.5.3 Large Biotechs and Pharmas Will Aggressively Defend their US Market Share 65
6.5.4 Patent Expirations of Blockbuster Biologics Will Encourage Biosimilar Developers 66
7 Biosimilars in Europe 67
7.1 Overview 67
7.2 EU Approved Biosimilars 67
7.3 Guidelines for Biosimilars Development in the EU 70
7.3.1 Sandoz Triggered the Development of Guidelines for Biosimilars in Europe 70
7.3.2 Applicable Guidance Documents on Biosimilars in Europe 71
7.3.3 Non-Clinical Data and Clinical Studies 72
7.4 Key Players and Pipelines 73
7.4.1 Sandoz 73
7.4.2 Stada Arzneimittel 76
7.4.3 Gedeon Richter 78
7.5 Biosimilars in Europe: Market Outlook 80
7.5.1 Financial Austerity Measures Will Further Drive the Uptake of Biosimilars 80
7.5.2 Companies Will Use the EU Biosimilars Market as a Springboard into the US Market 82
8 Biosimilars in Japan 83
8.1 Overview 83
8.2 Regulatory Framework 83
8.2.1 Organizational Structure 83
8.2.2 Biosimilars Review Process 84
8.2.3 Regulatory Guidelines 85
8.3 Key Players and Pipelines 87
8.3.1 Kyowa Hakko Kirin Co. Ltd. 87
8.3.2 JCR Pharmaceuticals 90
8.4 Biosimilars in Japan: Market Outlook 92
8.4.1 Cost Containment Measures Will Drive Biosimilars Development 92
8.4.2 CMOs Will Leverage Existing Capabilities to Enter Biosimilars Space 92
9 Biosimilars in India 93
9.1 Gradual Transition from a Semi-Regulated to a Regulated Market 93
9.2 Marketed Biosimilars in India 93
9.3 Regulatory Framework for Biosimilars in India 97
9.3.1 Guidelines on Similar Biologics, 2012 101
9.4 Key Players and Pipelines 102
9.4.1 Biocon 102
9.4.2 Dr. Reddy’s Laboratories 106
9.4.3 Ranbaxy Laboratories 108
9.4.4 Reliance Life Sciences 111
9.4.5 Cipla 112
9.5 India Biosimilars Market Outlook 114
9.5.1 Recent Biosimilar Guidelines Will Not Guarantee Approval by Regulators 114
9.5.2 Expertise in Generics Will Encourage Biosimilars Development 115
9.5.3 EU-India Free Trade Agreement Could Open Up Access to the European Market 115
10 Biosimilars in South Korea 117
10.1 Overview 117
10.2 Government Initiatives Aiding the Development of Biosimilars 119
10.3 Joint Ventures and Collaborations Enable Leveraging of Capabilities 120
10.4 Lack of Biologics’ Market Exclusivity Decelerates Time-to-Market 121
10.5 Regulatory Framework for Biosimilars 121
10.5.1 Extrapolation of Indications 123
10.6 Key Players and Pipelines 123
10.6.1 Celltrion 124
10.6.2 Hanwha Chemical 127
10.6.3 Samsung Bioepis 129
10.6.4 LG Life Sciences 129
10.7 Biosimilars in South Korea: Market Outlook 132
10.7.1 Government’s Initiatives Look Poised to Spur the Local Biosimilars Industry 132
10.7.2 Budding Pipeline Signals Boom for the Biosimilars Industry 133
11 Biosimilars in China 134
11.1 Overview 134
11.1.1 Soaring Healthcare Expenditures in China Drive Need for Cheaper Therapeutics 134
11.1.2 Biosimilars and Reimbursement 135
11.1.3 An Intellectual Property Loophole 136
11.2 Regulatory Framework for Biosimilars in China 136
11.3 Key Players and Pipelines 138
11.3.1 3SBio 138
11.3.2 Shandong Kexing Bioproducts 140
11.4 Biosimilars in China: Market Outlook 141
11.4.1 Ongoing Reform Will Boost Biosimilars Industry 141
11.4.2 Increase in Healthcare Access Bodes Well for Biosimilars in China 141
11.4.3 Collaborations between Multinationals and Domestic Companies Will Continue 142
12 Case Study: Teva Pharmaceutical Industries 143
12.1 Business Overview 143
12.2 Biosimilars at Teva 143
12.3 Product Portfolio/Pipeline 144
12.4 Company SWOT Analysis 145
12.4.1 Strengths 145
12.4.2 Weaknesses 147
12.4.3 Opportunities 147
12.4.4 Threats 149
13 Strategic Outlook 151
13.1 Patent Expiries Will Continually Fuel Biosimilars Development 151
13.2 Flurry of Regulatory and Legislative Activities Bodes Well for Biosimilars 151
13.3 Extensive Capabilities Needed Will Serve as a Barrier to Entry in the Near to Mid-term 152
13.4 EU-India FTA Will Significantly Benefit European and Indian Biosimilars Companies 153
13.5 Cost-containment Measures Are Expected to Drive Biosimilars Substitution 154
14 Appendix 156
14.1 Bibliography 156
14.2 Abbreviations 165
14.3 Research Methodology 168
14.3.1 Coverage 168
14.3.2 Secondary Research 169
14.4 About the Author 170
14.4.1 Adam Dion, Industry Analyst 170
14.5 Director of Healthcare Industry Dynamics 170
14.6 Global Head of Healthcare 171
14.7 About the Industry Dynamics Team 171
14.8 About GlobalData 172
14.9 Disclosure Information 172
14.10 Disclaimer 172

1.1 List of Tables

Table 1: Major Biologic Products 19
Table 2: Ongoing Biosimilar Clinical Trials 27
Table 3: Overview of Biosimilars Deals Analyzed in This Report 33
Table 4: Baxter International and Coherus Biosciences Biosimilars Collaboration 36
Table 5: Genor BioPharma and BioCND Licensing Deal 37
Table 6: Pfenex’s JV with Agila Biotech 38
Table 7: Viropro and Oncobiologics’ Biosimilars Deal 40
Table 8: Samsung Bioepis and Merck Sign Biosimilars Development Agreement 42
Table 9: Biosimilar Evaluation Requirements - WHO, South Korea, EU, and Japan 46
Table 10: Hospira: Marketed Biosimilars 58
Table 11: Hospira: Biosimilars Developmental Pipeline 59
Table 12: Actavis’ Biosimilars Pipeline 62
Table 13: Pfizer’s Biosimilars Pipeline 64
Table 14: Authorized Biosimilars in the EU 69
Table 15: Sandoz: Marketed Biosimilars 74
Table 16: Sandoz: Pipeline of Developmental Biosimilars 75
Table 17: Stada Arzneimittel’s Current Biosimilars Pipeline 78
Table 18: Gedeon Richter’s Current Biosimilars Pipeline 80
Table 19: Kyowa Hakko Kirin’s Late-stage Biologics Pipeline 89
Table 20: JCR Pharmaceuticals’ Product Pipeline 91
Table 21: Currently Marketed Biosimilars in India 95
Table 22: Guidelines Applicable to the Research, Development and Marketing of Biosimilars in India 102
Table 23: Biocon: Marketed Biologics 105
Table 24: Biocon: Current Developmental Biologics Pipeline 106
Table 25: Dr. Reddy’s: Marketed Biosimilars 108
Table 26: Ranbaxy’s Current Biosimilars Pipeline 110
Table 27: Reliance Life Sciences: Marketed Biosimilars 112
Table 28: Reliance Life Sciences: Pipeline Biosimilars 112
Table 29: Cipla Combined Annual Manufacturing Capacities 114
Table 30: Some Biosimilars in Development by South Korean Drug Companies 118
Table 31: Deals in the South Korean Biosimilars Industry 120
Table 32: Celltrion Product Pipeline 125
Table 33: Hanwha Chemical’s Current Product Pipeline 128
Table 34: LG Life Sciences’ Current Product Pipeline 132
Table 35: 3SBio’s Clinical Pipeline 140
Table 36: Teva Pharmaceutical Industries: Marketed and Developmental Biosimilars 145

1.2 List of Figures
Figure 1: Historical Sales of Branded Biologics, 2008-2013 and Forecast to 2019 21
Figure 2: New Biologics* Approvals by the FDA, 2006-2013 22
Figure 3: Groups of Companies Involved in Biosimilars Development 25
Figure 4: Trend in Deals in the Biosimilars Industry, 2007-2013 32
Figure 5: FDA-Recommended Stepwise Approach for Biosimilars’ Development in the US 52
Figure 6: Current Guidelines on Biosimilars Regulation in the EU 71
Figure 7: Novartis’ Capabilities being Leveraged by Sandoz 76
Figure 8: Public Debt and Budget Deficit-to-GDP Ratios in the Eurozone, 2013 81
Figure 9: PMDA’s Current Organizational Chart 84
Figure 10: Review Process for Biosimilars in Japan 85
Figure 11: Indian Regulatory Pathway for Indigenously Manufactured Biologics 99
Figure 12: Indian Regulatory Pathway for Imported Biologics 100
Figure 13: South Korean’s Three-tiered Regulatory System for Biosimilars 122
Figure 14: Celltrion Product Pipeline by Therapeutic Area 126
Figure 15: LG Life Sciences’ RandD Investment, 2009-2013 (Estimated) 131
Figure 16: Total and Government Healthcare Expenditures* in China, 2001-2011 135
Figure 17: Application and Approval Procedure for Pharmaceuticals in China 137
Figure 18: Teva’s Global Biosimilars Operation: A Recipe for Success 144
Figure 19: Teva Generics Sales in US vs. Rest-of-World (ROW), 2009-2012 149
Figure 20: Teva Pharmaceuticals: SWOT Analysis 150
Figure 21: Capabilities Needed for Biosimilars Development 153
Figure 22: US Healthcare Expenditure and GDP, 2001-2013 155

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