Biogenerics

Challenges and Promise

Publication Date	January 2005
Publisher	Arrowhead
Product Type	Report
Pages	154
ISBN Number	not applicable
Product Code	ARR00005

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Summary

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 new Arrowhead 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

Content

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
  - 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
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
- 5.1 Europe's Generic Sales as a Barometer for Future Biogeneric Growth
- 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
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
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
9 Biogenerics Market Potential for Products with Future Expired Patents
- 9.1 High-Profile Biotech Products at Risk of Biogeneric Competition
  - 9.1.1 Humulin
    - 9.1.1.1 Threats to Humulin
  - 9.1.2 Intron A
    - 9.1.2.1 Threats to Intron A
  - 9.1.3 Procrit
  - 9.1.4 Epogen
    - 9.1.4.1 Next Generation
  - 9.1.5 Neupogen
    - 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
- 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
- 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
  - 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
- 12.2 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
  - 12.3.2 Teva and Savient Involved in HGH Court Case
  - 12.3.3 Copaxone
  - 12.3.4 Teva Acquires Dorom
- 12.4 GeneMedix
- 12.5 Ivax
- 12.6 Microbix
- 12.7 Rhein Biotech
- 12.8 BioPartners GmbH
- 12.9 Transkaryotic Therapies (TKT)
- 12.10 BioGeneriX
Appendices
- Appendix I
- 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
List of Tables
- Table 2.1 Drugs That Must Demonstrate in Vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution
- Table 5.1 Biopharmaceuticals Nearing Generic Exposure
- Table 5.2 Factors Influencing Germany's Favorable Operating Environment
- Table 9.1 Blockbuster Biotechnology Products With Patent Expiry Before 2007
- Table 9.2 Biotech Products with Generic Equivalents Under Development
- Table 9.3 Sales of Humulin 2000-2003
- Table 9.4 Sales of Intron A 2000-2003
- Table 9.5 Sales of Procrit 2000-2003
- Table 9.6 Sales of Epogen 1999-2003
- Table 9.7 Sales of Neupogen 2002-2003
- Table 10.1 Factors That Could Hinder Generics' Production
- Table 11.1 Submitted Data to Demonstrate Bioavailability
- Table 11.2 Omnitrop's Recent History
- Table 12.1 Stada's Strengths
- Table 12.2 FDA-approved Generic Drugs Marketed by Teva Pharmaceutical
- Table 12.3 GeneMedix's Biogeneric Pipeline
- Table II Survey of Worldwide Data Exclusivity Legislation