Table of Contents for Biogenerics: Challenges and Promise
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
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
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
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
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
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
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
CMS, P&A House, Alma Road, Chesham, Bucks. HP5 3HB, UK
Tel: +44 (0)1494 771734
Fax: +44 (0)1494 778994
e-mail: jenniferc@cmsinfo.com
copyright © 2005 all rights reserved
For more information about us, visit CMSinfo.
