Biogenerics
Overview
Biogenerics: Challenges and Promise takes an insightful look at the burgeoning biogenerics industry and helps to clarify the complicated regulations that currently govern biogeneric development in both the US and Europe.
It provides vital information and analysis concerning the progress that the biogeneric industry continues to make, and the stumbling blocks that threaten the future vitality of this fledgling industry. It also pinpoints therapeutic areas that are ripe for biogeneric competition and highlights the progress of trailblazing companies active in both Europe and the US.
This report primarily focuses on how the generics industry will be shaped by the global healthcare market and regulatory developments over the next five years. The international biogenerics market faces a multitude of challenges. Biogenerics: Challenges and Promise will assess those challenges and analyze the potential for maximizing the myriad opportunities available in this competitive and dynamic industry. The report also appraises and compares current and emerging biogeneric products and identifies those with the most potential for growth.
Key questions answered in this report:
* Who are the major players in the biogenerics arena and what kind of impact are they making on the industry?
* What obstacles stand in the way of a smooth transition from biopharmaceutical manufacture to biogenerics?
* How has the lack of a clear framework impeded the industry�s progress in producing and distributing biogeneric drugs? And how will these issues be resolved?
* What specific hurdles must biogeneric manufacturers maneuver in order to get their products on the market?
This report contains:
* Thorough analysis of the drivers of and restraints on the biogenerics market
* Detailed information and analysis concerning groundbreaking biogeneric regulation in the US and Europe.
* Identification of key biopharmaceuticals at risk for biogeneric competition
* In-depth profiles of leading pharmaceutical companies involved in the biogenerics industry
* Analytical discussions which integrate regulatory issues with market activity and company activity
Table of Contents
- Table of Contents
- 1 Focus, Objectives and Methodology
- 1.1 Report Focus
- 1.2 Report Objectives
- 1.2.1 Industry Obstacles
- 1.2.2 The Road to Regulatory Standards
- 1.3 Report Methodology
- 2 Introduction to Biogenerics
- 2.1 Approval of Biogenerics
- 2.2 Establishment of Bioequivalence
- 2.2.1 Facilitating Bioequivalence
- Table 2.1 Drugs That Must Demonstrate in Vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution
- 2.2.2 Manufacturing Under Sameness
- 2.2.3 Generics/Biogenerics Definitions
- 2.2.4 FDA Approval for Generic Biologics
- 2.2.5 Criteria for Therapeutically-Equivalent Products
- 2.2.6 Differing Characteristics in Therapeutics Equivalence
- 2.3 Bioavailability and Bioequivalence Definitions
- 2.4 CDER Bioequivalence Codes
- 2.4.1 In Vitro Bioequivalence
- 3 Follow-on Biologics
- 3.1 Resemblance to Innovative Products
- 3.1.1 How Innovators and Follow-ons Differ
- 3.1.2 Intramanufacture Comparability
- 3.1.3 Complexity in Generic Biopharmaceutical Manufacture
- 3.1.4 Approval Process for Biologics
- 3.1.5 Legal and Regulatory Framework Creation
- 3.1 Resemblance to Innovative Products
- 4 Components of Potential Success and Stumbling Blocks
- 4.1 Shortsightedness of the Hatch-Waxman Act
- 4.2 Production Difficulty
- 4.3 Challenges for Biogenerics
- 4.4 Poorly Defined Definitions
- 4.5 Determining Comparability Pre- and Post-manufacturing Changes
- 4.6 Drawbacks for Generic Manufacturers
- 5 Financial Potential of Biogenerics
- Table 5.1 Biopharmaceuticals Nearing Generic Exposure
- 5.1 Europe's Generic Sales as a Barometer for Future Biogeneric Growth
- Table 5.2 Factors Influencing Germany's Favorable Operating Environment
- 5.2 Opportunities for Growth
- 5.3 Patent Terminations
- 6 Factors Influencing Market Potential
- 6.1 European Guidance
- 6.1.1 Complexity of Biosimilars Production
- 6.1.2 EMEA and FDA Guidelines
- 6.2 Rising Health Costs and Biogenerics
- 6.2.1 Governmental Measures to Promote Generics
- 6.3 Increasing Costs of Biologics
- 6.4 Beating High Prescription Costs with Biogenerics
- 6.1 European Guidance
- 7 Generic Industry Challenges
- 7.1 Manufacturing Difficulties and Capacity Shortages
- 7.1.1 Innovative Research and Development
- 7.1.2 Profit-margin Comparisons
- 7.1.3 NCE R&D Programs
- 7.2 Pliva's Success
- 7.3 Teva Focuses on NCE Products
- 7.4 IVAX Increases NCE Pipeline
- 7.5 Balancing NCE Activities and Generics
- 7.1 Manufacturing Difficulties and Capacity Shortages
- 8 Biogenerics Market Potential for Products with Current Expired Patents
- 8.1 Eliminating Federal Barriers
- 8.1.1 Clinical Data Transference
- 8.1.2 Non-competitive Flow of Information
- 8.2 Competitive Innovators and Follow-on Manufacturers
- 8.2.1 Clinical Properties' Differences
- 8.1 Eliminating Federal Barriers
- 9 Biogenerics Market Potential for Products with Future Expired Patents
- Table 9.1 Blockbuster Biotechnology Products With Patent Expiry Before 2007
- Table 9.2 Biotech Products with Generic Equivalents Under Development
- 9.1 High-Profile Biotech Products at Risk of Biogeneric Competition
- 9.1.1 Humulin
- 9.1 High-Profile Biotech Products at Risk of Biogeneric Competition
- Table 9.3 Sales of Humulin 2000-2003
- 9.1.1.1 Threats to Humulin
- 9.1.2 Intron A
- Table 9.4 Sales of Intron A 2000-2003
- 9.1.2.1 Threats to Intron A
- 9.1.3 Procrit
- Table 9.5 Sales of Procrit 2000-2003
- 9.1.4 Epogen
- Table 9.6 Sales of Epogen 1999-2003
- 9.1.4.1 Next Generation
- 9.1.5 Neupogen
- Table 9.7 Sales of Neupogen 2002-2003
- 9.1.5.1 Next Generation
- 9.2 Final Thoughts
- 10 Impediments to Biogenerics Market Development
- 10.1 Sandoz Files Suit Against the EC
- 10.2 Europe Takes Lead in Regulatory Procedure
- 10.3 FDA Considers Abbreviated Approval System
- 10.4 Interchangeability
- Table 10.1 Factors That Could Hinder Generics' Production
- 10.5 Complexity of Biotech Patents
- 10.6 Bio-giant Genentech Weighs In
- 10.7 Manufacturing Differences Resulting in Clinical Properties Differences
- 10.8 Challenges to the Production of Generic Equivalents
- 10.9 Proof of Comparability
- 10.10 Confusion Over Constitution of Generic Biologics
- 10.11 Detecting and Quantitating Impurities in Biologics
- 10.12 Specifications for Processes and Products
- 10.13 Demonstrating Safety and Efficacy in Biogenerics
- 10.14 Impurities in Follow-on Products
- 10.15 Data for Licensing Follow-ons
- 11 Regulatory and Legislative Issues
- 11.1 Annexe I revision
- 11.2 Regulation of "Biosimilars"
- 11.3 Initital Legal Framework
- 11.4 Additional Guidance Documents
- 11.5 Industry Reaction
- 11.6 CDER and EMEA Requisites for Biogeneric Approval
- 11.7 FDA Addresses Solutions to Regulatory Challenges
- 11.7.1 Comparability Protocols
- Table 11.1 Submitted Data to Demonstrate Bioavailability
- 11.8 In Vivo Bioequivalence Testing
- 11.9 Two One-sided Test Procedure
- 11.9.1 Bioequivalence Methodology
- 11.10 Protecting the Patient Through Regulation
- 11.11 Case Study: Sandoz and Omnitrop
- 11.11.1 Proving Bioequivalence
- 11.11.2 Omnitrop Could Set Precedents for FDA Approval
- Table 11.2 Omnitrop's Recent History
- 11.11.3 Sandoz Leads the Way
- 11.12 Licensing for Biologics
- 11.13 FDA Requirements for Biotech Drugs
- 11.14 Clinical Studies for Biogenerics' Approval
- 11.15 Direct Comparison Between Biologics
- 11.15.1 FDA Draft Guidance
- 12 Company Profiles and Activity
- 12.1 Stada
- 12.1.1 Uncertain Future
- 12.1 Stada
- Table 12.1 Stada's Strengths
- 12.2 Cangene
- 12.2.1 Cangene Waits for Next Big Wave
- 12.2.2 Human Growth Hormone
- 12.2.3 Therapeutical Equivalence for rhGH
- 12.3 Teva
- 12.3.1 Teva and Active Biotech
- 12.2 Cangene
- Table 12.2 FDA-approved Generic Drugs Marketed by Teva Pharmaceutical
- 12.3.2 Teva and Savient Involved in HGH Court Case
- 12.3.3 Copaxone
- 12.3.4 Teva Acquires Dorom
- 12.4 GeneMedix
- Table 12.3 GeneMedix�s Biogeneric Pipeline
- 12.5 Ivax
- 12.6 Microbix
- 12.7 Rhein Biotech
- 12.8 BioPartners GmbH
- 12.9 Transkaryotic Therapies (TKT)
- 12.10 BioGeneriX
- Appendix I
- Table I Therapeutic Biologics Under the Auspices of the Center for Drug Evaluation and Research (CDER)
- Appendix II
- CBER (Center for Biologics Evaluation and Research)-Licensed Establishments and Products
- Appendix III
- EU Guidance
- Appendix IV
- Data Exclusivity Legislation
- Table II Survey of Worldwide Data Exclusivity Legislation
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