Sections
Title | Starting Page | Number of Pages |
---|
Table of Contents | 5 | 8 |
List of Tables | 8 | 2 |
List of Figures | 10 | 3 |
Introduction | 13 | 1 |
Biosimilars in Developed Countries- Market Overview | 14 | 8 |
Introduction | 14 | 1 |
Biologics and Small Molecules | 15 | 1 |
Structural Differences between Biologics and Small Molecules | 15 | 1 |
Market Size and Patent Expiries of Branded Biologics | 16 | 1 |
Market Size of Branded Biologics &Sales by Major Drug Classes in 2010 | 16 | 1 |
Top Ten Biologics in 2010 | 17 | 1 |
Patent Expiry of Leading Biologics, 2011 2018 | 18 | 1 |
Approved Biosimilars in Europe until December 2011 | 19 | 1 |
Biopharmaceutical and Biosimilars Manufacturing and Development Process | 20 | 1 |
Manufacturing Process | 20 | 1 |
Setting up a new biosimilar manufacturing facility | 21 | 1 |
Development Process &Cost | 21 | 1 |
Biosimilars in Developed Countries- Geographic Landscape | 22 | 48 |
Introduction | 22 | 1 |
Global Biosimilar Market | 23 | 1 |
Market Size and Forecast | 23 | 2 |
Drivers and Barriers | 25 | 1 |
US Biosimilar Market | 26 | 1 |
Market Size and Forecast | 26 | 2 |
Regulatory Landscape | 28 | 1 |
Objectives of Biosimilar Legislation and Regulatory Frameworks | 29 | 1 |
Comparison of the biosimilar with reference biologic | 29 | 1 |
Level of clinical trial data and duration of the study adequate for the biosimilar approval | 29 | 1 |
Prerequisites for post-marketing safety evaluation studies | 29 | 1 |
Standards and criteria for the interchangeability of the biosimilar | 29 | 1 |
Incentives to innovator company R&D through Intellectual Property protection and market exclusivity. | 29 | 1 |
Regulatory Framework for Biopharmaceutical Industry | 30 | 3 |
Evolution of Regulatory Pathways for Biosimilars | 33 | 3 |
BPCI Act and the Pathway for Approval of Biosimilar Products | 36 | 1 |
Biosimilarity vs. Interchangeability | 36 | 1 |
FDA Guidance Documents | 36 | 1 |
Contents of the Biosimilar Application - Clinical Studies | 37 | 1 |
Differences between Biosimilar and Interchangeable Biosimilar Products | 37 | 1 |
Market and Data Exclusivity | 38 | 1 |
Patent Dispute Procedure | 38 | 2 |
Notice of Commercial Marketing | 40 | 1 |
Other Provisions | 40 | 1 |
Substitution is a Decision Taken at Local Level | 41 | 1 |
Drivers and Barriers | 42 | 1 |
Top Five European Markets- Biosimilar Market Size and Forecast | 43 | 1 |
Introduction | 43 | 1 |
Market Size and Forecast | 43 | 2 |
Regulatory Framework for Biopharmaceutical Industry | 45 | 1 |
Evolution of Regulatory Pathways for Biosimilars | 46 | 1 |
Current Position on Biosimilars | 47 | 1 |
Overarching Guidelines | 47 | 1 |
Quality Guidelines | 47 | 1 |
Non-Clinical and Clinical Guidelines | 48 | 1 |
Annexes Product Specific Guidelines | 48 | 1 |
Post-Authorization Requirements | 48 | 1 |
Data Exclusivity Period | 49 | 1 |
What does this mean for the biosimilar industry? | 49 | 1 |
The Bolar Type Provision | 50 | 1 |
The Comparability Exercise | 50 | 2 |
Biosimilars Approvals and Applications | 52 | 2 |
EMA Guidelines for Biosimilar mAb | 54 | 1 |
European Biosimilars Industry- Issues | 54 | 1 |
Naming | 55 | 1 |
Labeling | 55 | 1 |
Substitution/Interchangeability | 55 | 1 |
Pharmacovigilance | 55 | 1 |
Drivers and Barriers | 56 | 1 |
Country Analysis The UK | 57 | 1 |
Structure of the Healthcare System | 57 | 1 |
Pricing and Reimbursement Mechanisms | 57 | 1 |
Drivers and Barriers for Biosimilars | 58 | 1 |
Country Analysis Germany | 58 | 1 |
Structure of the Healthcare System | 58 | 1 |
Pricing and Reimbursement Mechanisms | 59 | 1 |
Drivers and Barriers for Biosimilars | 59 | 1 |
Country Analysis France | 60 | 1 |
Structure of the Healthcare System | 60 | 1 |
Pricing and Reimbursement Mechanisms | 60 | 1 |
Drivers and Barriers for Biosimilars | 61 | 1 |
Country Analysis Spain | 62 | 1 |
Structure of the Healthcare System | 62 | 1 |
Pricing and Reimbursement Mechanisms | 62 | 1 |
Drivers and Barriers for Biosimilars | 63 | 1 |
Country Analysis Italy | 64 | 1 |
Structure of the Healthcare System | 64 | 1 |
Pricing and Reimbursement Mechanisms | 64 | 1 |
Drivers and Barriers for Biosimilars | 64 | 1 |
Japan Biosimilars Market Size and Forecasts | 65 | 1 |
Market Size and Forecast | 65 | 1 |
Regulatory Landscape in Japan | 66 | 1 |
Regulatory Framework for Biopharmaceutical Industry | 66 | 1 |
Evolution of Regulatory Pathways for Biosimilars | 67 | 1 |
Current Position on Biosimilars | 68 | 1 |
Approved Biosimilars | 68 | 1 |
Drivers and Barriers | 69 | 1 |
Biosimilars in Developed Countries Market Characterization | 70 | 28 |
Human Growth Hormone Biosimilars Market | 70 | 1 |
Pipeline molecules | 71 | 1 |
Drivers and barriers | 72 | 1 |
Erythropoietin (EPO) Biosimilars Market | 73 | 2 |
Pipeline molecules | 75 | 1 |
Drivers and barriers | 76 | 1 |
Granulocyte-Colony Stimulating Factor (G-CSF) Biosimilars Market | 77 | 2 |
Pipeline molecules | 79 | 1 |
Drivers and barriers | 80 | 1 |
Interferon alpha Biosimilars Market | 81 | 1 |
Pipeline molecules | 82 | 1 |
Interferon beta Biosimilars Market | 82 | 1 |
Pipeline molecules | 83 | 1 |
Interferon alpha and Interferon beta Drivers and Barriers | 84 | 1 |
Insulin and Insulin Analogs Biosimilars Market | 85 | 2 |
Pipeline molecules | 87 | 1 |
Drivers and barriers | 88 | 1 |
TNF-alpha Inhibitor Biosimilars Market | 89 | 2 |
Pipeline molecules | 91 | 1 |
Drivers and barriers | 92 | 1 |
Biosimilars Market for Monoclonal Antibodies against Cancer | 93 | 2 |
Pipeline molecules | 95 | 2 |
Drivers and barriers | 97 | 1 |
Biosimilars in Developed Countries- Case Study | 98 | 11 |
Market Share of Biosimilars in Top Five European Markets | 98 | 1 |
Market Share Filgrastim | 98 | 1 |
Market Share- Somatropin | 98 | 1 |
Market Share- EPO | 99 | 1 |
Pricing of Biosimilars in Top Five European Markets | 100 | 2 |
Strategies Adopted By Branded Biologic Companies to Beat Generic Competition | 102 | 1 |
Introduction | 102 | 1 |
Second Generation Biologics | 102 | 1 |
New Formulation | 103 | 1 |
Combination Products | 103 | 1 |
New Approved Indications | 104 | 1 |
Caps | 104 | 1 |
Industry Dynamics- Strategies to Be Adopted by Companies to Enter the Biosimilar Market | 105 | 1 |
Product | 106 | 1 |
Regulatory and Clinical Expertise | 106 | 1 |
Capital Investment | 106 | 1 |
Manufacturing Capability | 106 | 1 |
Price | 106 | 1 |
Discount to originator | 106 | 1 |
Reimbursement | 106 | 1 |
Competitors Pricing | 107 | 1 |
Place | 107 | 1 |
Market Segment to Target | 107 | 1 |
Prescribing trends | 107 | 1 |
Sustainability of originator | 107 | 1 |
Promotion | 107 | 1 |
Customized Sales and Marketing | 107 | 1 |
Differentiation | 108 | 1 |
People | 108 | 1 |
Decision Makers- Prescribers | 108 | 1 |
Decision Makers- Payers | 108 | 1 |
Biosimilars in Developed Countries-Competitive Landscape | 109 | 9 |
Celltrion | 109 | 1 |
Company Profile | 109 | 1 |
SWOT Analysis | 109 | 1 |
Dr Reddy s Laboratories | 110 | 1 |
Company Profile | 110 | 1 |
SWOT Analysis | 110 | 1 |
Hospira | 111 | 1 |
Company Profile | 111 | 1 |
SWOT Analysis | 111 | 1 |
Biocon | 112 | 1 |
Company Profile | 112 | 1 |
SWOT Analysis | 112 | 1 |
Teva Pharmaceuticals Ltd | 113 | 1 |
Company Profile | 113 | 1 |
SWOT Analysis | 113 | 1 |
Sandoz | 114 | 1 |
Company Profile | 114 | 1 |
SWOT Analysis | 114 | 1 |
3SBio | 115 | 1 |
Company Profile | 115 | 1 |
SWOT Analysis | 115 | 1 |
Intas Pharma | 116 | 1 |
Company Profile | 116 | 1 |
SWOT Analysis | 116 | 1 |
Samsung Biologics | 117 | 1 |
Company Profile | 117 | 1 |
SWOT Analysis | 117 | 1 |
Biosimilars in Developed Countries- Strategic Consolidations | 118 | 16 |
Deals by Type | 118 | 1 |
Mergers &Acquisitions (M&A) | 119 | 1 |
M&A Deals by Year | 119 | 1 |
M&A Deals by Value | 120 | 1 |
M&A Deals by Geography | 121 | 1 |
M&A Deals in 2011 | 122 | 1 |
SemBioSys Genetics Completes Private Placement of Bonds for $4.01m | 122 | 1 |
Therapeutic Proteins Secures $2.5m in the Second Tranche of Venture Financing Round | 122 | 1 |
Teva Completes Acquisition of Cephalon | 122 | 1 |
Licensing Agreements in the Biosimilars Market | 123 | 1 |
Licensing Agreements By Year | 123 | 1 |
Licensing Agreements By Value | 124 | 1 |
Licensing Agreements By Geography | 125 | 1 |
Licensing Agreement Deals | 126 | 1 |
Richter Gedeon Enters Into Licensing Agreement With STADA Arzneimittel For Rituximab | 126 | 1 |
Richter Gedeon Enters Into Licensing Agreement With STADA Arzneimittel For Trastuzumab | 126 | 1 |
Hanwha Chemical Enters Into Licensing Agreement With Merck For HD203 | 127 | 1 |
Compass Biotechnologies Enters Into Licensing Agreement With Arecor | 127 | 1 |
Viropro Enters Into Licensing Agreement With Spectrum Pharmaceuticals For Rituximab | 127 | 1 |
Co- Development Deals | 128 | 1 |
Co-Development Deals By Year | 128 | 1 |
Co-Development Deals By Value | 129 | 1 |
Co-Development Deals By Geography | 130 | 1 |
Co-Development Deals | 131 | 1 |
Amgen Enters Into Co-Development Agreement With Watson For Generic Cancer Drugs | 132 | 1 |
Samsung Forms Joint Venture With Biogen Idec For Biosimilars | 132 | 1 |
Samsung and Quintiles Team Up for Co-Development of Biosimilar | 132 | 1 |
Baxter International Enters Into Co-Development Agreement with Momenta Pharmaceuticals for Biologics | 133 | 1 |
Biosimilars in Developed Countries- Appendix | 134 | 8 |
Market Definitions | 134 | 1 |
Abbreviations | 135 | 2 |
Bibliography | 137 | 2 |
Research Methodology | 139 | 3 |
Market Overview | 140 | 1 |
Methodology | 140 | 1 |
Sources of Coverage | 140 | 1 |
Geographic Landscape | 140 | 1 |
Methodology | 140 | 1 |
Sources of Coverage | 140 | 1 |
Market Characterization | 140 | 1 |
Methodology | 140 | 1 |
Sources of Coverage | 140 | 1 |
Case Study | 141 | 1 |
Methodology | 141 | 1 |
Sources of Coverage | 141 | 1 |
Competitive Landscape | 141 | 1 |
Methodology | 141 | 1 |
Sources of Coverage | 141 | 1 |
Strategic Consolidations | 141 | 1 |
Methodology | 141 | 1 |
Sources of Coverage | 141 | 1 |
Contact Us | 141 | 1 |
Disclaimer | 141 | 1 |