[Report]
Business Strategies for Different Types of Biogenerics
Published: 2007/11
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Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Biogenerics Are Already on Today's Markets
- Understanding the Market for Different Types of Biologics
- Erythropoiesis-Stimulating Proteins
- Granulocyte Colony-Stimulating Factor
- Human Growth Hormone
- Insulin and Insulin Analogues
- Regular Insulins
- Insulin Analogues
- Neutral Protamine Hagedorn Insulins
- Interferon Alphas
- Keeping Abreast of an Evolving Regulatory Landscape
- Understanding How the Process Defi nes the Product
- Trade Secrets
- Unexpected Clinical Effects
- Selecting the Right Comparator
- Legal Impediments
- Commercial Considerations
- Establishing a Manufacturing Process
- Establishing Comparability
- Preclinical Studies
- Clinical Development
- Pharmacodynamic Markers
- Safety Database
- Target Indications
- Minimum Clinical Trial Requirements
- Anticipating Long-Term Studies of Immunogenicity
- Planning a Flexible Pricing Strategy to Refl ect Changing Market
Competition
- Developing Effective Promotion Strategies for Physicians
- Biogenerics Outlook
- Appendix. Abbreviations and Defi nitions
Tables:
- 1. The EMEA's General Biosimilars Guidelines as of August 2007
- 2. The EMEA's Product-Specifi c Biosimilars Guidelines as of August 2007
- 3. The EMEA's Recommended Pharmacodynamic Markers
- 4. The EMEA's Recommended Clinical Trial Durations
- 5. The EMEA's Recommended Target Indications
Figures:
- 1. Nine Business Strategies for Use in Developing Biogenerics
- 2. Current Market for Select Erythropoiesis-Stimulating Proteins (ESPs)
- 3. Current Market for Select Granulocyte Colony-Stimulating Factors
(G-CSFs)
- 4. Current Market for Select Human Growth Hormones
- 5. Current Market for Insulin and Insulin Analogues
- 6. Current Market for Select Interferon Alphas
- 7. Minimum Clinical Trial Requirements for Biogenerics
- 8. Main Drivers of Biogenerics Use: U.S. Physicians
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[Report]
Business Strategies for Different Types of Biogenerics
Published: 2007/11
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Published by : Decision Resources, Inc.  |
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Price:
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Product Code : DR56476 |
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