Biogenerics: Challenges and Promise

  • ID: 239049
  • November 2004
  • Arrowhead Publishers
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This brand new report takes an insightful look at the burgeoning biogenerics industry.

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 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

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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 Threats to Humulin

9.1.2 Intron A

Table 9.4 Sales of Intron A 2000-2003 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 Next Generation

9.1.5 Neupogen

Table 9.7 Sales of Neupogen 2002-2003 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

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