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 United States Europe 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
