Sections
| Title | Starting Page | Number of Pages |
|---|
| Table of Contents | 6 | 5 |
| List of Tables | 9 | 1 |
| List of Figures | 10 | 1 |
| Introduction | 11 | 1 |
| Biosimilars in Emerging Economies Market Overview | 12 | 12 |
| Biosimilars | 12 | 1 |
| Types of Biosimilars | 12 | 1 |
| Human Growth Hormone | 12 | 1 |
| Erythropoietin | 12 | 1 |
| Granulocyte Colony-Stimulating Factor | 13 | 1 |
| Interferon Alpha | 13 | 1 |
| Interferon Beta | 14 | 1 |
| Insulin and Insulin Analogs Biosimilar | 14 | 1 |
| | 15 | 1 |
| Monoclonal Antibodies against Cancer | 15 | 1 |
| Comparison of Biosimilars with Biologics and Generics | 16 | 1 |
| Structural Differences between Biologics, Generics and Biosimilars | 17 | 1 |
| Development of Biosimilars | 18 | 1 |
| Manufacturing of Biosimilars | 19 | 1 |
| Establishing a New Biosimilar Manufacturing Facility | 19 | 1 |
| Drivers and Restraints | 20 | 1 |
| Drivers | 20 | 1 |
| Restraints | 21 | 1 |
| Top 10 Biologics in 2010 | 22 | 1 |
| Patent Expiries of Leading Biologics | 23 | 1 |
| Price Comparison of Biosimilars and Reference Products | 23 | 1 |
| Biosimilars in Emerging Economies Market Characterization | 24 | 4 |
| Biosimilars Market Size and Forecast for Emerging Economies | 24 | 1 |
| Major Marketed Biosimilars in Emerging Economies | 25 | 3 |
| Biosimilars in Emerging Economies India | 28 | 14 |
| Biosimilars Market Overview | 28 | 1 |
| Key Market and R&D Trends | 29 | 1 |
| Biocon s Deal to Commercialize Biosimilar Versions of Insulin Products with Pfizer Cancelled | 29 | 1 |
| Regulatory Landscape in India | 29 | 1 |
| Regulatory Framework for Biosimilars | 29 | 1 |
| Challenges and Opportunities | 30 | 1 |
| Challenges | 30 | 1 |
| Unsafe Biosimilars Saturating Indian Market due to Lack of Regulations | 30 | 1 |
| Opportunities | 30 | 1 |
| Government Encouraging Biosimilar Development | 30 | 1 |
| Indian Companies to Reduce the Price of Biologics | 31 | 1 |
| Key Companies | 31 | 1 |
| Dr. Reddy s Laboratories (DRL) | 31 | 1 |
| Company Profile | 31 | 1 |
| Marketed Biosimilar Products | 31 | 1 |
| SWOT Analysis | 32 | 1 |
| Biocon | 32 | 1 |
| Company Profile | 32 | 1 |
| Marketed Biosimilar Products | 33 | 1 |
| Pipeline Portfolio | 33 | 1 |
| SWOT Analysis | 33 | 1 |
| Intas Biopharmaceuticals (IBPL) | 34 | 1 |
| Company Profile | 34 | 1 |
| Marketed Biosimilar Products | 34 | 1 |
| SWOT Analysis | 35 | 1 |
| Reliance Life Sciences | 36 | 1 |
| Company Profile | 36 | 1 |
| Marketed Biosimilar Products | 36 | 1 |
| Pipeline Portfolio | 37 | 1 |
| SWOT Analysis | 37 | 1 |
| Wockhardt | 38 | 1 |
| Company Profile | 38 | 1 |
| Marketed Biosimilar Products | 38 | 1 |
| SWOT Analysis | 38 | 1 |
| Lupin | 39 | 1 |
| Company Profile | 39 | 1 |
| Pipeline Portfolio | 39 | 1 |
| SWOT Analysis | 39 | 1 |
| Cipla | 40 | 1 |
| Company Profile | 40 | 1 |
| Pipeline Portfolio | 40 | 1 |
| SWOT Analysis | 41 | 1 |
| Biosimilars in Emerging Economies China | 42 | 7 |
| Biosimilars Market Overview | 42 | 1 |
| Marketed Biosimilars in China | 43 | 1 |
| Regulatory Landscape in China | 43 | 1 |
| Regulatory Framework for Biosimilars | 43 | 1 |
| Challenges and Opportunities | 44 | 1 |
| Challenges | 44 | 1 |
| Technical Difficulties for mAb and EPO Production | 44 | 1 |
| Key Companies | 44 | 1 |
| 3SBio | 44 | 1 |
| Company Profile | 44 | 1 |
| Marketed Biosimilar Products | 44 | 1 |
| Pipeline Portfolio | 45 | 1 |
| SWOT Analysis | 45 | 1 |
| Shanghai CP Guojian Pharmaceutical Co. Ltd. | 46 | 1 |
| Company Profile | 46 | 1 |
| Marketed Biosimilar Products | 46 | 1 |
| Pipeline Portfolio | 46 | 1 |
| SWOT Analysis | 47 | 1 |
| Biotech Pharma | 47 | 1 |
| Company Profile | 47 | 1 |
| Marketed Biosimilar Products | 47 | 1 |
| SWOT Analysis | 48 | 1 |
| Biosimilars in Emerging Economies Other Emerging Economies | 49 | 11 |
| Brazil | 49 | 1 |
| Biosimilars Regulatory Framework and Approval Process | 49 | 1 |
| Biosimilars Coverage and Availability at Reduced Cost | 49 | 1 |
| Biosimilars Market Opportunity | 49 | 1 |
| Brazil to Manufacture Humira Biosimilar | 50 | 1 |
| Major Challenge | 50 | 1 |
| Abbreviated Approval of Biosimilars Poses a Risk to Patients | 50 | 1 |
| Russia | 50 | 1 |
| Mexico | 50 | 1 |
| Turkey | 51 | 1 |
| Biosimilar Guidelines in Turkey | 51 | 1 |
| Risk Management Plan | 52 | 1 |
| New Pharmacovigilance Legislation | 52 | 1 |
| Actavis and Bioton Collaborate for Insulin | 53 | 1 |
| Argentina | 53 | 1 |
| Major Challenge | 53 | 1 |
| South Africa | 53 | 1 |
| Guidelines for Similar Biological Medicines | 54 | 1 |
| Biosimilars are not Interchangeable | 54 | 1 |
| Genius Biotherapeutics | 54 | 1 |
| Major Challenges | 55 | 1 |
| Venezuela | 55 | 1 |
| Vietnam | 56 | 1 |
| Innogene Kalbiotech | 56 | 1 |
| Kalbenox/Kalparin | 56 | 1 |
| Leucogen | 57 | 1 |
| Hemapo | 57 | 1 |
| Major Challenge | 57 | 1 |
| Counterfeit Drugs Dissuading International R&D Ventures in Vietnam due to Lack of IP Protection | 57 | 1 |
| Generic Version of Drugs being Sidelined due to Corrupt Practices | 57 | 1 |
| Thailand | 58 | 1 |
| Major Challenges | 59 | 1 |
| Biosimilars in Emerging Economies Pipeline Analysis | 60 | 11 |
| Introduction | 60 | 2 |
| R&D Pipeline Filed | 62 | 1 |
| R&D Pipeline Phase III | 62 | 2 |
| R&D Pipeline Phase II | 64 | 1 |
| R&D Pipeline Phase I | 64 | 1 |
| R&D Pipeline Pre-clinical | 65 | 2 |
| R&D Pipeline Discovery | 67 | 1 |
| R&D Pipeline IND Filed | 68 | 3 |
| Biosimilars in Emerging Economies Industry Dynamics | 71 | 5 |
| Strategies Adopted By Branded Biologic Companies to Beat Generic Competition | 71 | 1 |
| Introduction | 71 | 1 |
| Second Generation Biologics | 72 | 1 |
| New Formulation | 72 | 1 |
| Combination Products | 72 | 1 |
| New Approved Indications | 73 | 1 |
| Industry Dynamics: Strategies to Be Adopted by Companies to Enter the Biosimilars Market | 73 | 1 |
| Product | 74 | 1 |
| Regulatory and Clinical Expertise | 74 | 1 |
| Capital Investment | 74 | 1 |
| Manufacturing Capability | 74 | 1 |
| Price | 74 | 1 |
| Discount to Originator | 74 | 1 |
| Competitors Pricing | 74 | 1 |
| Place | 75 | 1 |
| Market Segment to Target | 75 | 1 |
| Prescribing Trends | 75 | 1 |
| Promotion | 75 | 1 |
| Customized Sales and Marketing | 75 | 1 |
| Differentiation | 75 | 1 |
| People | 75 | 1 |
| Decision Makers: Prescribers | 75 | 1 |
| Decision Makers: Payers | 75 | 1 |
| Biosimilars in Emerging Economies Deals Analysis | 76 | 8 |
| Mergers and Acquisitions | 76 | 1 |
| M&A by Year | 76 | 1 |
| M&A by Value | 77 | 1 |
| M&A by Type | 77 | 1 |
| M&A Deals | 78 | 1 |
| Biocon Acquired an Additional 7.4% Stake in AxiCorp | 79 | 1 |
| Cipla Acquired a Minority Stake in MabPharm | 79 | 1 |
| Reliance Life Sciences Acquired a Majority Stake in GeneMedix | 79 | 1 |
| Cipla Acquired a Minority Stake in BioMab | 79 | 1 |
| Strides Arcolab Acquired a 70% Stake in Inbiopro Solutions | 80 | 1 |
| Licensing Agreements | 80 | 1 |
| Abraxis BioScience Entered Into Licensing Agreement with Biocon for G-CSF | 81 | 1 |
| Dowpharma Entered Into Licensing Agreement with Biovel Life Sciences | 81 | 1 |
| Lupin Entered Into Licensing Agreement with Neuclone | 81 | 1 |
| Natco Pharma Entered Into Licensing Agreement with Mabxience | 82 | 1 |
| Co-developments | 82 | 1 |
| Ranbaxy Labs Entered Into a Co-Development Agreement with Pfenex | 82 | 1 |
| Apotex Extended Co-Development Agreement with IBPL | 83 | 1 |
| Mylan Entered Into Agreement with Biocon | 83 | 1 |
| Apotex Extended Collaboration with IBPL | 83 | 1 |
| Ranbaxy Labs Entered Into Agreement with Zenotech Labs | 83 | 1 |
| Biosimilars in Emerging Economies - Appendix | 84 | 7 |
| Market Definitions | 84 | 1 |
| Abbreviations | 84 | 2 |
| Bibliography | 86 | 2 |
| Research Methodology | 88 | 3 |
| Market Overview | 89 | 1 |
| Methodology | 89 | 1 |
| Sources of Coverage | 89 | 1 |
| Market Characterization | 89 | 1 |
| Methodology | 89 | 1 |
| Sources of Coverage | 89 | 1 |
| India | 89 | 1 |
| Methodology | 89 | 1 |
| Sources of Coverage | 89 | 1 |
| China | 89 | 1 |
| Methodology | 89 | 1 |
| Sources of Coverage | 89 | 1 |
| Other Emerging Economies | 89 | 1 |
| Methodology | 89 | 1 |
| Sources of Coverage | 89 | 1 |
| Pipeline Analysis | 90 | 1 |
| Methodology | 90 | 1 |
| Sources of Coverage | 90 | 1 |
| Industry Dynamics | 90 | 1 |
| Methodology | 90 | 1 |
| Sources of Coverage | 90 | 1 |
| Deals Analysis | 90 | 1 |
| Methodology | 90 | 1 |
| Sources of Coverage | 90 | 1 |
| Contact Us | 90 | 1 |
| Disclaimer | 90 | 1 |
