Follow-on Biologics: Working with the Federal Trade Commission

In this Presentation:

- Agenda

- BPCIA Refresher

- FDA Developments - Purple Book, FDA Review of Applications, Draft Guidance, Abbott Petition

- The Naming Issue

- State Substitution Laws

- Excerpt from The FDA Draft Guidances:

Three of them released in 2012 – scientific considerations in demonstrating biosimilarity, quality considerations in demonstrating biosimilarity and Q and A regarding implementation (biosimilarity v. interchangeability, exclusivity and definition of a biological product).

- FDA intends to release final versions in 2014.

Please see Full Presentation below for more information.

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Published In: Intellectual Property Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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