Biosimilars 2012: U.S. Implementation - Practical Strategies for Originators, Biosimilar Companies and Litigation
June 25, 2012
CLE - Live Seminar
USA
Description
The roll-out of the new U.S. pathway for biosimilars is underway, with the FDA’s Draft Guidelines recently published for comment. The unique U.S. pathway presents significant issues and questions for biosimilars applicants, Reference Product Owners, and the FDA, as each prepares for the first wave of U.S. biosimilar applications. The panel will discuss these issues as well as practical strategies for implementation.
- What companies are doing to prepare for the expected wave of biosimilars applications
- Strategic approaches for protecting the reference product’s exclusivity, trade secrets, and business concerns
- The FDA’s approach for examining a product to be biosimilar and/or interchangeable
- What types of data may be required to achieve biosimilarity under the FDA’s “totality of the evidence” approach
- How to navigate the U.S. pathway’s patent exchange and litigation scheme
Organized by
Practising Law Institute
810 Seventh Avenue
New York, New York
USA
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