Biosimilars and Follow-On Biologics: World Market 2013-2023

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1. Executive Summary
1.1 Biosimilar Drugs: World Market Overview 2013-2023 1.2 Report Contents 1.3 Research and Analysis Methods 1.4 Terminology Used in this Report

2. An Introduction to Biosimilars
2.1 Biological and Biosimilar Drugs 2.1.1 What Is a Biosimilar Drug? 2.2 Key Classes of Biologics and Biosimilars 2.2.1 Monoclonal Antibodies 2.2.2 Insulin for Diabetes 2.2.3 Interferons Are Used for Multiple Sclerosis and Hepatitis 2.2.4 Erythropoietin (EPO) 2.2.5 Granulocyte Colony Stimulating Factor (G-CSF) 2.2.6 Human Growth Hormone 2.2.7 Fertility Hormones 2.3 Why Is There Demand for Biosimilars? 2.4 Considerations for the Development of Biosimilars

3. The World Biosimilar Drugs Market 2013-2023

3.1 The World Biologics Market 2012 3.1.1 Strong Growth for the Biologics Market 2013-2023 3.2 Biosimilars Account for a Small Proportion of Biologics Revenues 3.2.1 The Biosimilars Market: Overall Revenue Forecast 2013-2023 3.2.2 How Will Biosimilar Submarket Shares Change 2013-2023?

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3.3 What Will Drive Growth in the Biosimilars Market 2013-2023? 3.4 Biosimilar Market Restraints 2013-2023

4. Commercial and Regulatory Outlook for Biosimilars in Leading National Markets 2013-2023
4.1 Which Were the Leading National Markets for Biosimilar Sales in 2012? 4.2 Which National Markets Will Grow Fastest to 2023? 4.2.1 National Market Shares 2013-2023 4.3 The Outlook for Biosimilars in the US 2013-2023 4.3.1 Final FDA Biosimilar Guidelines Expected in 2013 4.3.2 Legal Challenges for Biosimilars in the US 4.3.3 State Regulation of Biosimilar Substitution 4.3.4 US Biosimilars Submarket Forecast 2013-2023 4.4 Biosimilars Market Outlook in the EU 2013-2023 4.4.1 The EU Led the World in Biosimilar Regulation 4.4.2 The EMA Continues to Update Biosimilar Guidelines 4.4.3 EMA Simplifies Biosimilar Development in the EU 4.4.4 Two New Biosimilar Classes to Launch in the EU in 2013-2014 4.4.5 The EU Biosimilars Submarket by Country 2012 4.4.6 The EU Biosimilars Submarket Forecast 2013-2023 4.4.7 Germany: The Largest National Market for Biosimilars in the EU 4.4.8 France: Biosimilars Submarket 2013-2023 4.4.9 Biosimilar Uptake is High in the UK 4.4.10 Spain Has the Highest Biosimilar Discounting in Western Europe 4.4.11 Biosimilar Uptake Will Rise in Italy 2013-2023 4.5 The Outlook for Biosimilars in Japan 2013-2023 4.5.1 Regulatory Processes for Biosimilars in Japan 4.5.1.1 Regulations for Naming Biosimilars 4.5.2 Two New Biosimilars Will Be Launched in Japan in 2013

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4.5.3 Japanese Biosimilar Submarket Forecast 2013-2023 4.6 The Chinese Biosimilar Submarket 2013-2023 4.6.1 China to Release Formal Biosimilar Development Guidelines 4.6.2 Strong Growth for the Chinese Biosimilars Market 2013-2023 4.7 India: The Second Largest Biosimilars National Market 2013 4.7.1 India Releases New Biosimilar Development Guidelines 4.7.2 Indian Biosimilars Submarket Forecast 2013-2023 4.8 Brazil: Biosimilars Submarket Outlook 2013-2023 4.8.1 ANVISAs Biosimilar Regulations Are Similar to the EMAs 4.8.2 Brazilian Biosimilars Submarket Forecast 2013-2023 4.9 Russia 4.9.1 No Specific Biosimilar Legislation Exists in Russia 2013 4.9.2 Russian Biosimilars Submarket Forecast 2013-2023 4.10 South Korea 4.10.1 KFDA Introduced Biosimilar Guidelines in 2009 4.10.2 There Has Been Significant Investment in Biosimilars in South Korea 4.10.3 South Korean Biosimilars Submarket Forecast 2013-2023

5. Biosimilar Monoclonal Antibodies Submarket 2013-2023

5.1 The World Monoclonal Antibodies (MAbs) Submarket 2012 5.1.1 Outlook for the MAbs Submarket 2013-2023 5.2 The Biosimilar MAbs Submarket 2013-2023 5.2.1 Biosimilar MAbs Submarket Forecast 2013-2023 5.2.2 Large Market Potential to Drive Growth to 2023 5.2.3 What Will Restrain Growth for the Biosimilar MAbs Submarket 2013-2023? 5.2.3.1 There Have Been Delays in Biosimilar Antibody Development 5.2.3.2 There Are Challenges in Developing Biosimilar MAbs 5.3 How Has the Industry Reacted to New EMA Development Guidelines? 5.4 Collaboration in Biosimilar MAb Development

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5.5 Rituximab: The Most Popular Biosimilar MAb Target? 5.5.1 Increasing Incidence of Non-Hodgkins Lymphoma 2013-2023 5.5.2 The Outlook for Roches Rituxan 2013-2023 5.5.3 Reditux: Indias First Biosimilar MAb 5.5.4 Kikuzubam: Probiomeds Biosimilar Rituximab 5.5.5 Biosimilar Rituximab Development for Developed Markets 5.5.6 Biosimilar Rituximab Development in Emerging Markets 5.5.7 Biosimilar Rituximab: Revenue Forecast 2013-2023 5.6 Infliximab Will Be the First Developed Market Biosimilar MAb 5.6.1 How Will Rheumatoid Arthritis Prevalence Change in this Decade? 5.6.2 Biosimilars Must Compete With Novel Therapies 5.6.3 Remsima: The Worlds First Biosimilar Infliximab 5.6.4 Epirus Biopharmaceuticals: Developing Biosimilar Infliximab for the US Market 5.6.5 Reliance Life Sciences: Biosimilar Infliximab in India 5.6.6 Biosimilar Infliximab: Revenue Forecast 2013-2023 5.7 Biosimilar Trastuzumab 5.7.1 Roche Has Developed a Next Generation Breast Cancer Therapy 5.7.2 Biosimilar Pipeline for Trastuzumab 2013 5.7.2.1 Celltrion Is Leading Biosimilar Development in Emerging Markets 5.7.2.2 Biosimilars in Developed Markets 5.7.3 Biosimilar Trastuzumab: Revenue Forecast 2013-2023 5.8 Other Biosimilar MAbs in Development 5.8.1 Humira is the Worlds Bestselling Drug 5.8.1.1 AbbVie Seeks to Protect its Bestselling Drug 5.8.1.2 Biosimilar Adalimumab Pipeline 2013 5.8.2 Biosimilar Etanercept Development Has Been Delayed 5.8.2.1 Biosimilar Etanercept in Emerging Markets 5.8.3 ReoPro: Limited Biosimilar Potential

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6. Biosimilar Insulin Submarket 2013-2023
6.1 The Insulin Therapy Submarket 2013-2023 6.1.1 Outlook for the Insulin Therapy Submarket 2013-2023 6.1.2 The Rising Incidence of Diabetes Worldwide 2013-2023 6.1.2.1 Obesity and Ageing Will Drive Rising Incidence 6.1.3 What Potential Is There for Oral Insulin? 6.1.4 The Cost of Insulin Therapy as a Driver for Biosimilar Uptake 6.2 The Biosimilar Insulin Submarket 2013-2023 6.2.1 Biosimilar Insulin Submarket Forecast 2013-2023 6.2.2 Collaborative Agreements in Biosimilar Insulin 6.2.3 EMA Publishes Draft Guidelines for Biosimilar Insulin 6.3 The Biosimilar Human Insulin Submarket 2013-2023 6.3.1 Human Insulin Biosimilars Are Popular in Emerging Markets 6.3.2 Approval Application Withdrawals in the EU 2007-2012 6.3.3 Biosimilar Human Insulin Uptake in China 6.3.4 Biosimilar Human Insulin in India 6.3.5 Biosimilar Human Insulin Revenue Forecast 2013-2023 6.4 Biosimilar Fast-Acting Insulin Analogues 2013-2023 6.4.1 Few Insulin Lispro Biosimilars Are Approved in Emerging Markets 6.4.2 Biosimilar Fast-Acting Insulin Analogues Submarket Forecast 2013-2023 6.5 Biosimilar Long-Acting Insulin Analogues 2013-2023 6.5.1 Two Insulin Glargine Biosimilars Are Marketed in India 6.5.2 Development of Ultra-Long Acting Insulin Analogues 6.5.3 Biosimilar Long-Acting Insulin Analogues Submarket Forecast 2013-2023

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7. Biosimilar Interferon Submarket Outlook 2013-2023
7.1 The Interferon Therapy Submarket 2013-2023 7.1.1 The Threat of Oral Therapies in Hepatitis C and MS 7.2 Biosimilar Interferons in the EU 7.2.1 Failed Development Attempts 7.2.2 New EMA Development Guidelines Released 2013 7.2.3 What Challenges Exist in Developing Interferon Biosimilars? 7.3 Biosimilar Interferon Alpha Submarket 2013-2023 7.3.1 Limited Demand for Interferon Alpha Therapy in Hepatitis C to 2023 7.3.2 Many Companies Already Market Biosimilar Interferon Alpha 7.3.3 Biosimilar Peginterferon Alpha Development 7.3.4 The Prevalence of Hepatitis C Will Rise 2013-2023 7.3.5 Biosimilar Interferon Alpha Submarket Forecast 2013-2023 7.4 Biosimilar Interferon Beta Submarket 2013-2023 7.4.1 Interferon Beta in Emerging Markets 2013 7.4.2 Biosimilar Interferon Beta Submarket Forecast 2013-2023

8. Outlook for Other Leading Biosimilar Submarkets 2013-2023

8.1 The Biosimilar Erythropoietin (EPO) Submarket 2013-2023 8.1.1 Branded EPO Submarket 2012 8.1.2 Branded EPO Submarket Outlook 2013-2023: Revenues Will Continue to Decline 8.1.3 Erythropoietins Come With Safety Concerns 8.1.4 The Rising Risk of Chronic Kidney Disease 2013-2023 8.1.5 The Biosimilar EPO Submarket in Europe 2013 8.1.5.1 Companies Are Preparing to Launch in the US 8.1.5.2 JCR Pharmaceuticals and Kissei Market Biosimilar EPO in Japan 8.1.6 Many Companies Offer Biosimilar EPO in India

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8.1.7 Developing Second Generation EPO Biosimilars 8.1.8 Biosimilar EPO Submarket Forecast 2013-2023 8.2 The Biosimilar Filgrastim Submarket 2013-2023 8.2.1 Filgrastim Submarket Outlook 2013-2023 8.2.2 The Biosimilar Filgrastim Submarket 2012 8.2.3 What Trends Are There in Biosimilar Cost and Uptake in Europe? 8.2.4 Biosimilar Pegfilgrastim in India: An Increasingly Fragmented Market Driving Down Prices 8.2.5 Pegfilgrastim Is a More Lucrative Target in the US 8.2.6 Biosimilar Filgrastim Submarket Forecast 2013-2023 8.3 The Biosimilar Somatropin Submarket 2013-2023 8.3.1 A Competitive Branded Submarket 2013-2023 8.3.2 Product Lifecycle Management to Maintain Market Share 8.3.3 Limited Uptake for Biosimilar Somatropin in the US and EU 8.3.4 Biosimilar Somatropin in Emerging Markets 8.3.5 Biosimilar Somatropin Submarket Forecast 2013-2023 8.4 The Biosimilar Follicle Stimulating Hormone (FSH) Market 2013-2023 8.4.1 Patents Expiries Affecting Leading Therapies 2009-2015 8.4.2 EMA Releases Biosimilar FSH Guidelines 2013 8.4.3 Infertility Is a Common Problem Worldwide 8.4.4 Biosimilar FSH Will Be Launched in the EU in 2013 8.4.5 Biosimilars FSH Submarket Forecast 2013-2023

9. Biosimilars and Follow-On Biologics: Industry Trends 2013-2023

9.1 What Are the Strengths and Weaknesses of the Biosimilars Market in 2013? 9.2 Opportunities and Threats for Biosimilars Developers 2013-2023 9.3 Biosimilars Market: STEP Analysis 2013-2023 9.3.1 Social Factors 9.3.2 Technological Developments Will Simplify Biosimilar Production

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9.3.3 Economic Pressures Driving Biosimilar Demand 9.3.4 Political Issues: Patent Challenges, Data Exclusivity and Regulatory Pathways 9.3.4.1 Regularly Updated Guidelines Will Benefit Developers 9.3.4.2 International Cooperation Is Required 9.4 Opportunities and Challenges in Biosimilar Development 9.4.1 Biologics and Biosimilars Are Large, Complex Molecules 9.4.2 Clinical Trials Are Required for Biosimilars 9.4.3 How Big a Concern Is Immunogenicity? 9.4.4 Outsourcing to Gain Biological Expertise 9.4.5 Biosimilars Are Expensive to Develop 9.5 Considerations for Commercialising Biosimilars 9.5.1 Biosimilars Need Branding 9.5.1.1 Marketing Strategy and Doctors Response to Biosimilars 9.5.2 Biosimilars Can Offer Cost Savings 9.5.2.1 Pricing Strategies for Biosimilars 9.5.3 The Importance of Naming Biosimilars 9.5.3.1 There Is Not Yet Automatic Substitution for Biosimilars 9.5.4 Protecting Important Biological Assets 9.5.4.1 Intellectual Property Challenges 9.5.4.2 Data Exclusivity for New Biologics 9.5.4.3 Biobetters as a Threat to Biosimilars 9.6 Key Players in the Biosimilars Market 2013-2023 9.6.1 Big Pharma Will Play an Increasing Role in the Biosimilars Market 9.6.2 Collaborative Agreements to Bring Biosimilars to New Markets

10. Research Interviews

10.1 Dr Terence Ryan, SVP, iBio 10.1.1 iBio and its Biosimilar Pipeline, 2013 10.1.2 The Benefits of the iBioLaunch Platform

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10.1.3 Differences Between Developing Biosimilar and Biologics 10.1.4 Product Differentiation in the Biosimilar Market 10.1.5 Biosimilars and Immunogenicity 10.1.6 Challenges in Developing Biosimilars for the US Market 10.2 Anjan Selz, CEO, Finox 10.2.1 Finox 10.2.2 Challenges in Biosimilar Development 10.2.3 Differences Between Europe and the US 10.2.4 Product Differentiation 10.2.5 Opportunities Existing in the Biosimilars Market

11. Conclusions from Our Study

11.1 The World Biosimilars Market in 2012 11.1.1 Growth for the Market 2013-2023 11.1.2 Which National Markets Will Dominate in 2023? 11.2 The Biosimilars Pipeline Is Long 11.3 Opportunities for Companies Looking to Enter the Market

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List of Tables
Table 1.1 Currency Exchange Rates, 2012 Table 2.1 Comparison of Major Biological Drug Classes by Size Table 2.2 Monoclonal Antibody Classification Table 2.3 Insulin Peak Action Times Table 3.1 Top Ten Prescription Drugs by Revenue, 2012 Table 3.2 Biologics Market by Sector, 2012 Table 3.3 Next Generation Development for Biologics, 2013 Table 3.4 Biosimilars Market by Sector, 2012 Table 3.5 Biosimilars Market: Overall Market and Revenue Forecasts by Sector, 2012-2023 Table 3.6 Biosimilars Market: Submarket Shares, 2013-2023 Table 3.7 Biosimilars Market: Drivers and Restraints, 2013-2023 Table 4.1 Biosimilars Market by Country: Revenues and Market Shares, 2012 Table 4.2 Biosimilars Market: Revenue Forecasts by Country, 2012-2023 Table 4.3 Biosimilar Market: National Submarket Shares, 2012-2023 Table 4.4 US Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.5 European Approved Biosimilars, 2013 Table 4.6 EU Biosimilars Submarket by Country, 2012 Table 4.7 EU Biosimilars Submarket: Revenue Forecasts by Country, 2012-2023 Table 4.8 German Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.9 French Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.10 UK Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.11 Spanish Biosimilars Submarket: Revenue Forecast, 2012-2023

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Table 4.12 Italian Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.13 Japanese Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.14 Selected Chinese Biosimilar Manufacturers and their Activities, 2013 Table 4.15 Chinese Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.16 Indian Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.17 Brazilian Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.18 Russian Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 4.19 South Korean Biosimilars Submarket: Revenue Forecast, 2012-2023 Table 5.1 Monoclonal Antibody (MAb) Submarket by Drug: Revenues, 2011-2012 Table 5.2 Blockbuster MAbs: US and EU Patent Expiries, 2013-2022 Table 5.3 Biosimilar MAbs Submarket and Leading Drugs: Revenue Forecasts, 2012-2023 Table 5.4 Biosimilar MAbs Submarket: Drivers and Restraints, 2013-2023 Table 5.5 EMA Biosimilar Mab Development Guidelines: Key Points, 2013 Table 5.6 Selected Collaborations for Biosimilar MAb Development, 2009-2013 Table 5.7 Rituxan: Revenue by Company, 2011-2012 Table 5.8 Reditux: Revenue, 2008-2012 Table 5.9 Biosimilar Rituximab: Selected Pipeline, 2013 Table 5.10 Biosimilar Rituximab: Revenue Forecast, 2012-2023 Table 5.11 Remicade: Revenue by Company, 2011-2012 Table 5.12 Rheumatoid Arthritis: Prevalence, 2013 Table 5.13 Biosimilar Infliximab: Selected Pipeline, 2013 Table 5.14 Biosimilar Infliximab: Revenue Forecast, 2012-2023 Table 5.15 Herceptin: Revenue, 2010-2012 Table 5.16 Biosimilar Trastuzumab: Selected Pipeline, 2013 Table 5.17 Biosimilar Trastuzumab: Revenue Forecast, 2012-2023

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Table 5.18 Biosimilar Adalimumab: Selected Pipeline, 2013 Table 5.19 Biosimilar Etanercept: Selected Pipeline, 2013 Table 6.1 Insulin Therapy Submarket by Sector, 2012 Table 6.2 Diabetes: Global Prevalence by Country, 2013 Table 6.3 Population Ageing in Developed and Emerging Markets, 2010 and 2050 Table 6.4 Biosimilar Insulin Submarket: Drivers and Restraints, 2013-2023 Table 6.5 Biosimilar Insulin Submarket and Leading Sectors: Revenue Forecasts, 2012-2023 Table 6.6 Human Insulin Submarket by Company: Revenues, 2011-2012 Table 6.7 Chinese Insulin Market by Company: Shares, 2011 Table 6.8 Biosulin: Revenue, 2009-2011 Table 6.9 Biosimilar Human Insulin Submarket: Revenue Forecast, 2012-2023 Table 6.10 Fast-Acting Insulin Analogue Submarket by Drug: Revenues, 2011-2012 Table 6.11 Biosimilar Fast-Acting Insulin Analogues Submarket: Revenue Forecast, 2012-2023 Table 6.12 Long-Acting Insulin Analogue Submarket by Drug: Revenues, 2011-2012 Table 6.13 Biosimilar Long-Acting Insulin Analogues Submarket: Revenue Forecast, 2012-2023 Table 7.1 Interferon Submarket by Sector, 2011-2012 Table 7.2 Leading Phase III Oral Hepatitis C Therapies, 2013 Table 7.3 Marketed Oral MS Therapies, 2013 Table 7.4 Interferon Alpha Submarket by Drug: Revenues, 2011-2012 Table 7.5 Pegasys: Revenue, 2008-2012 Table 7.6 Interferon Alpha and Beta: US and EU Patent Expiries Table 7.7 Selected Interferon Alpha Biosimilars Available in Emerging Markets, 2013 Table 7.8 Selected Peginterferon Alpha Biosimilars Available and in Development in Emerging Markets, 2013 Table 7.9 Hepatitis C: Global Prevalence by Region, 2013

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Table 7.10 Biosimilar Interferon Alpha Submarket: Revenue Forecast, 2012-2023 Table 7.11 Interferon Beta Submarket by Drug: Revenues, 2011-2012 Table 7.12 Selected Interferon Beta Biosimilars Available in Emerging Markets, 2013 Table 7.13 Biosimilar Interferon Beta Submarket: Revenue Forecast, 2012-2023 Table 8.1 Erythropoietin (EPO) Market by Drug: Revenues, 2011-2012 Table 8.2 EPO Biosimilars Available in Developed Markets, 2013 Table 8.3 Binocrit and Silapo: Revenue, 2009-2011 Table 8.4 EPO: US and EU Patent Expiries Table 8.5 Retacrit: US Phase III Trials, 2013 Table 8.6 Selected Biosimilar Erythropoietins Available in Emerging Markets, 2013 Table 8.7 EPIAO: Revenue, 2009-2012 Table 8.8 Espogen: Revenue, 2006-2012 Table 8.9 Biosimilar EPO Submarket: Drivers and Restraints, 2013-2023 Table 8.10 Biosimilar Erythropoietins Submarket: Revenue Forecast, 2012-2023 Table 8.11 Filgrastim Submarket by Drug: Revenues, 2011-2012 Table 8.12 Biosimilar Filgrastim Products Marketed in the EU, 2013 Table 8.13 Selected Biosimilar Filgrastim Products Marketed in Emerging Markets, 2013 Table 8.14 Biosimilar Pegfilgrastim Products Marketed in India, 2013 Table 8.15 Filgrastim and Pegfilgrastim: US and EU Patent Expiries Table 8.16 Biosimilar Filgrastim Submarket: Revenue Forecast, 2012-2023 Table 8.17 Biosimilar Filgrastim Submarket: Drivers and Restraints, 2013-2023 Table 8.18 Somatropin Submarket by Drug: Revenues, 2011-2012 Table 8.19 Omnitrope: National Market Launches, 2004-2011 Table 8.20 Selected Biosimilar Somatropin Products Available in Emerging Markets, 2013 Table 8.21 Growtropin: Revenue, 2009-2012

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Table 8.22 Biosimilar Somatropin Submarket: Drivers and Restraints, 2013-2023 Table 8.23 Biosimilar Somatropin Submarket: Revenue Forecast, 2012-2023 Table 8.24 Follicle Stimulating Hormone (FSH) Submarket by Drug: Revenues, 2011-2012 Table 8.25 FSH: US and EU Patent Expiries Table 8.26 Biosimilar FSH Submarket: Drivers and Restraints, 2013-2023 Table 8.27 Biosimilar FSH Submarket: Revenue Forecast, 2012-2023 Table 9.1 Biosimilars Market: Strengths and Weaknesses, 2012-2013 Table 9.2 Biosimilars Market: Opportunities and Threats, 2013-2023 Table 9.3 Biosimilars Market: STEP Analysis, 2013-2023 Table 9.4 Outsourcing Deals in the Biosimilars Industry, 2011-2012 Table 9.5 Selected Biosimilars Marketed in Pen Injectors, 2013 Table 9.6 Websites for EU and US Marketed Biosimilars, 2013 Table 9.7 Biosimilar Market Leaders by Revenue, 2012 Table 9.8 Big Pharmas Role in the Biosimilars Market, 2013 Table 9.9 Selected Biosimilar Industry Partnerships, 2009-2013 Table 11.1 Biosimilars Market by Sector, 2012, 2017 and 2023 Table 11.2 Biosimilars Market by Country, 2012, 2017 and 2023

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List of Figures
Figure 3.1 Biologics Market by Sector: Shares, 2012 Figure 3.2 Biologics Market Forecast, 2012, 2017 and 2023 Figure 3.3 Biosimilars Market by Sector: Shares, 2012 Figure 3.4 Biosimilars Market Forecast, 2012-2023 Figure 3.5 Biosimilars Market by Sector: Shares, 2017 Figure 3.6 Biosimilars Market by Sector: Shares, 2023 Figure 4.1 Biosimilars Market by Country: Shares, 2012 Figure 4.2 Biosimilars Market by Country: Shares, 2017 Figure 4.3 Biosimilars Market by Country: Shares, 2023 Figure 4.4 FDA Biosimilar Guidelines 2012: Key Points Figure 4.5 US Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.6 EU Biosimilars Submarket by Country: Shares, 2012 Figure 4.7 EU Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.8 German Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.9 French Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.10 UK Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.11 Spanish Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.12 Italian Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.13 Japanese Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.14 Chinese Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.15 Indian Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.16 Brazilian Biosimilars Submarket: Revenue Forecast, 2012-2023

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Figure 4.17 Russian Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 4.18 South Korean Biosimilars Submarket: Revenue Forecast, 2012-2023 Figure 5.1 Monoclonal Antibody (MAb) Submarket by Drug: Shares, 2012 Figure 5.2 Biosimilar MAbs Submarket: Revenue Forecast, 2012-2023 Figure 5.3 Rituxan: Revenue by Company, 2011-2012 Figure 5.4 Reditux: Revenue, 2008-2012 Figure 5.5 Biosimilar Rituximab: Revenue Forecast, 2012-2023 Figure 5.6 Remicade: Revenue by Company, 2011-2012 Figure 5.7 Biosimilar Infliximab: Revenue Forecast, 2012-2023 Figure 5.8 Herceptin: Revenue, 2010-2012 Figure 5.9 Biosimilar Trastuzumab: Revenue Forecast, 2012-2023 Figure 6.1 Insulin Therapy Submarket by Sector: Shares, 2012 Figure 6.2 Diabetes: Global Prevalence by Country, 2013 Figure 6.3 Biosimilar Insulin Submarket: Revenue Forecast, 2012-2023 Figure 6.4 Human Insulin Submarket by Company, 2012 Figure 6.5 Chinese Insulin Market by Company: Shares, 2011 Figure 6.6 Biosulin: Revenue, 2009-2011 Figure 6.7 Biosimilar Human Insulin Submarket: Revenue Forecast, 2012-2023 Figure 6.8 Fast-Acting Insulin Analogue Submarket by Drug: Shares, 2012 Figure 6.9 Biosimilar Fast-Acting Insulin Analogues Submarket: Revenue Forecast, 2012-2023 Figure 6.10 Long-Acting Insulin Analogue Submarket by Drug: Shares, 2012 Figure 6.11 Biosimilar Long-Acting Insulin Analogues Submarket: Revenue Forecast, 2012-2023 Figure 7.1 Interferon Submarket by Sector: Shares, 2012 Figure 7.2 Interferon Alpha Submarket by Drug: Shares, 2012 Figure 7.3 Hepatitis C: Global Prevalence by Region, 2013

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Figure 7.4 Biosimilar Interferon Alpha Submarket: Revenue Forecast, 2012-2023 Figure 7.5 Interferon Beta Submarket by Drug: Shares, 2012 Figure 7.6 Biosimilar Interferon Beta Submarket: Revenue Forecast, 2012-2023 Figure 8.1 Erythropoietin (EPO) Submarket by Drug: Shares, 2012 Figure 8.2 Binocrit and Silapo: Revenue, 2009-2011 Figure 8.3 EPIAO: Revenue, 2009-2012 Figure 8.4 Espogen: Revenue 2006-2012 Figure 8.5 Biosimilar Erythropoietins Submarket: Revenue Forecast, 2012-2023 Figure 8.6 Filgrastim Submarket by Drug, 2012 Figure 8.7 Biosimilar Filgrastim Submarket: Revenue Forecast, 2012-2023 Figure 8.8 Somatropin Submarket by Drug: Shares, 2012 Figure 8.9 Growtropin: Revenue, 2009-2012 Figure 8.10 Biosimilar Somatropin Submarket: Revenue Forecast, 2012-2023 Figure 8.11 Follicle Stimulating Hormone (FSH) Submarket by Drug: Shares, 2012 Figure 8.12 Biosimilar FSH Submarket: Revenue Forecast, 2012-2023 Figure 9.1 Biosimilar Start-Up and Development Cost Estimates, 2013 Figure 9.2 Biosimilar Market Leaders by Revenue: Shares, 2012 Figure 11.1 Biosimilars Market, 2012, 2017 and 2023 Figure 11.2 Biosimilars Market by Region, 2012, 2017 and 2023

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Companies Mentioned in This Report
3SBio AbbVie Ach Actavis (formerly Watson Pharmaceuticals) AET BioTech Agila Biotech Allozyne Amega Biotech Amgen Antares Pharma Apotex Aprogen AstraZeneca Avesthagen Baxter International Bayer Beijing Four Rings Biopharmaceutical Beijing SL Pharmaceutical Biocad Bioceuticals Arzneimittel (part of Stada) Biocon Biogen Idec BioGeneriX (part of Teva) BioGenomics Bionovis Biopartners (part of Bioton) Biosidus

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Bioton BioXpress Therapeutics Boehringer Ingelheim Bristol-Myers Squibb CCL Pharmaceuticals Celltrion Centocor Ortho Biotech (now Janssen Biotech part of J&J) Chiron (part of Novartis) Chugai Pharmaceutical (part of Roche) CinnaGen Cipla CJ Corporation Coherus BioSciences Compass Biotechnologies CT Arzneimittel (part of Teva) Daiichi Sankyo Dong-A Pharmaceutical Dr. Reddy's Laboratories Egis Pharmaceuticals Eli Lilly Emcure Pharmaceuticals EMS Epirus Biopharmaceuticals EvaluatePharma (now Evaluate) Finox Fresenius Kabi Fuji Pharma Fujifilm Fujifilm Kyowa Kirin Biologics Gan & Lee Pharmaceutical

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Gedeon Richter Genentech (part of Roche) GeneScience Pharmaceuticals (GenSci) Genexine Gennova Biopharmaceuticals (part of Emcure Pharmaceuticals) Genzyme (part of Sanofi) Getz Pharmaceuticals Gilead Sciences GSK Hangzhou Jiuyuan Gene Engineering Hanwha Chemical Haselmeier Hexal (part of Novartis) Hikma Pharmaceuticals Hospira Hualida Biotech Hypermarcas iBio ImmunoGen IMS Health Incepta Pharmaceuticals Insmed Intas Biopharmaceuticals InterMune Isu Abxis J&J JCR Pharmaceuticals Kissei Pharmaceutical Kyowa Hakko Kirin Laboratrios Biosinttica (part of Ach)

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Landsteiner Scientific LG Life Sciences Lonza Mabion Marvel Life Sciences Medice MedImmune Medipolis Medivir Merck & Co. Merck Serono Minapharm Pharmaceuticals Mitsubishi Tanabe Pharma Mochida Pharmaceutical Momenta Pharmaceuticals Mycenax Biotech Mylan Nichi-Iko Pharmaceutical Nippon Kayaku Novartis Novo Nordisk Nuron Biotech Octoplus Oncobiologics Oramed Pharmaceuticals Owen Mumford Parexel International Pfenex Pfizer Pharmapark (part of Pharmstandard)

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PharmaPraxis Pharmstandard PlantForm Pliva (part of Teva) Polfa Tarchomin PRA International Probiomed Prolor Biotech Protalix Biotherapeutics Qilu Pharmaceutical Quintiles Ranbaxy Laboratories ratiopharm (part of Teva) Reliance GeneMedix (pat of Reliance Life Sciences) Reliance Life Sciences Rentschler Biotechnologie Roche Samsung Samsung Bioepis Samsung BioLogics Sandoz (part of Novartis) Sanofi Schnell Biopharmaceuticals SciGen (part of Bioton) Shandong Kexing Bioproducts Shanghai Celgen Bio-Pharmaceutical Shanghai CP Guojian Pharmaceutical Shanghai Fosun Pharmaceutical Shantha Biotechnics (part of Sanofi) Sicor Biotech (part of Teva)

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Sothema Laboratories Spectrum Pharmaceuticals Square Pharmaceuticals Stada Arzneimittel Sundiro Pharma Synthon Teva Pharmaceutical Industries Tibotec Pharmaceuticals (part of J&J) Tonghua Dongbao UCB Unio Qumica United Laboratories USV Biologics Viropro Wanbang Biopharmaceuticals (part of Shanghai Fosun Pharmaceutical) Wockhardt Wolters Kluwer Xiamen Amoytop Biotech Ypsomed Zenotech Laboratories Zenyaku Kogyo Zuventus Healthcare (part of Emcure Pharmaceuticals) Zydus Cadila

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Government Agencies and Other Organisations Mentioned in This Report
Agence nationale de scurit du mdicament et des produits de sant (ANSM) [France] Agncia Nacional de Vigilncia Sanitria (ANVISA) [Brazil] American Cancer Society American Diabetes Association Biopharmaceuticals and Herbal Medicines Bureau [South Korea] Biotechnology Industry Organization (BIO) Cambridge University Cardiovascular and Renal Drugs Advisory Committee [US] Centers for Disease Control and Prevention (CDC) [US] Central Drugs Standard Control Organisation (CDSCO) [India] Centers of Medicare and Medicaid Services (CMS) [US] Comisin Federal para la Proteccin contra Riesgos Sanitarios (Cofepris) [Mexico] Congressional Budget Office [US] Department of Biotechnology (DBT) [India] Drug Controller General of India (DCGI) EMA Committee for Medicinal Products for Human Use (CHMP) [EU] European Medicines Agency (EMA) Food and Drug Administration (FDA) [US] Fraunhofer Institute [Germany] Fundao Ezequiel Dias (Funed) [Brazil] Health Canada Instituto Vital Brazil Intellectual Property Appellate Board (IPAB) [India] Korea Food and Drug Administration (KFDA) Medicines and Healthcare Products Regulatory Agency (MHRA) [UK] Ministry of Health, Labor and Welfare (MHLW) [Japan]

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Ministry of Health [Brazil] National Health Service (NHS) [UK] National Institute for Health and Care Excellence (NICE) [UK] National Institute for the Control of Pharmaceutical and Biological Products [China] Pharmaceutical Research and Manufacturers of America (PhRMA) Pro Generika [Germany] State Food and Drug Administration (SFDA) [China] State's Employees Social Security and Social Services Institute (ISSSTE) [Mexico] Therapeutic Goods Administration (TGA) [Australia] University of California, Los Angeles (UCLA) University of Michigan US Patent and Trademark Office Walter and Eliza Hall Institute of Medical Research Washington Legal Foundation World Economic Forum World Health Organization (WHO)

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Biosimilars and Follow-On Biologics: World Market 2013-2023

4.4.8 France: Biosimilars Submarket 2013-2023
Compared with other leading Western European nations, pharmaceutical spending, per capita, is high in France, while generic drug use is low. In France, low uptake of generics is a result of comparatively low prices for branded drugs, as well as many patents for leading products being extended in the country. Low uptake of generics is matched there by low uptake of biosimilars, when compared other leading nations such as the UK and Germany. In France, biosimilars account for only around 15% of prescriptions in the EPO, filgrastim and somatropin markets. For EPO, the level of biosimilar uptake is estimated to be just 5%. In that submarket, as well as for growth hormones, low uptake is the result of mandatory price reductions for the reference biologics and biosimilars. These price reductions mean that there is little difference between the cost of the reference biologic and the biosimilar. Generally speaking, though, biosimilars are launched at a discount of 20% over the reference biologics in France.

Reports suggest that doctors in France have not yet gained confidence in prescribing biosimilars, giving another possible explanation as to why uptake remains low. The reason given is that biosimilars are relatively new to the market - confidence in these drugs will grow in the coming 10 years, visiongain predicts. This growing confidence will drive revenues to $321m in 2017, up from $61m in 2012 (Table 4.9 and Figure 4.9). Growth in the second half of the forecast period will be driven by the launch of biosimilar mAbs. By 2023, the French biosimilars submarket will be worth $1,146m, having grown since 2012 with a CAGR of 30.6%. Visiongain predicts that France will fall further behind Germany, in terms of market size, although its European market share will increase relative to that country.

Table 4.9 French Biosimilars Submarket: Revenue Forecast, 20122023

2012 Submarket ($m) Annual Growth (%) CAGR (%) 2018 Submarket ($m) Annual Growth (%) CAGR (%) 423 32 2019 547 29 2020 682 25 2021 832 22 2022 977 18 61 2013 75 23 2014 119 58 2015 170 44 2016 236 39 2017 321 36 39.4 2023 1,146 17 23.7

Source: visiongain 2013

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Biosimilars and Follow-On Biologics: World Market 2013-2023

Figure 4.9 French Biosimilars Submarket: Revenue Forecast, 2012-2023
1,200

1,000

Market Size ($m)

800

600

400

200

0 2012

2013

2014

2015

2016

2017

2018 Year

2019

2020

2021

2022

2023

Source: visiongain 2013

4.4.9 Biosimilar Uptake is High in the UK

In 2012, biosimilar revenues in the UK totalled $40m, accounting for 12.5% of the EU biosimilars submarket. Uptake for biosimilars in the UK is higher than for France, with around two thirds of NHS filgrastim prescriptions being filled with biosimilars. Price and cost effectiveness are two important features of the UK pharmaceutical market, visiongain notes. However, upon launch discounts for biosimilars are not as high as has been seen in other countries. For example, In July 2009, Sandoz Zarzio was launched on the UK market with a 10% discount over Neupogen, although this may be the result of a low price for the reference biologic. Pricing is a key element of entering the UK market, with only drugs found to be cost-effective - as determined by the criteria of the National Institute for Health and Care Excellence (NICE) - available through the NHS. While generic drugs are exempt from pricing regulation schemes in the UK, biosimilars are covered.

As with other leading European markets, biosimilar substitution is not possible in the EU. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced a number of safeguards to prevent against accidental substitution. In 2008, for example, it advised that doctors should always prescribe biological drugs by brand name to avoid confusion for the pharmacist. In addition, packaging for biosimilars in the UK must be printed with a black triangle to identify the product as a follow-on biologic. The UK was among the first countries to introduce such a regulation, although similar EU-wide rules are set to take effect in 2013.

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