Listing Requirements
| Chapter 7 | Generics for Biologic Drugs |
Early Approvals of Biologic Generics
Biosimilars and Interchangeables
Exclusivity for Branded Biologics (BLAs)
Patent Dispute Procedures for Biosimilars
Biosimilar Litigation under BPCIA
FDA Guidance on Biosimilar Development
European Regulation of Biosimilars
Biosimilars in India and Canada
| Chapter 8 | Putting it All Together: Product Life-Cycle Management |
U.S. Patent Term Adjustments and Extensions
Litigation over Patent Term Extensions
Scope of Patent Term Extensions
New Dosage Forms/Delivery/Conditions of Use
Orange Book Listing and De-listing
Over-The-Counter (OTC) Strategy
Examples of Life-Cycle Management
The Alphagan (brimonidine) Story
| Chapter 9 | Conclusions and Final Thoughts |
Drug Policy v. Industrial Policy
Uniform International Approval Standards
Price Controls and “free ride” Issues
Prescribing Generic Drugs Even More Often
Disclaimer
This book is intended to provide information about the subject matter covered. It is sold with the understanding that the publisher and author are not engaged in rendering legal services or providing legal advice. If legal advice is required, the services of a competent legal adviser should be obtained.
Reasonable efforts have been made to make this book accurate as well as informative. However, there may be mistakes, both typographical and in content, or omissions.
