Daniel M. Becker, M.D.

Daniel M. Becker, M.D.

Dechert LLP

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FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval

As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal...more

3/13/2014 - Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars FDA FTC Pharmaceutical

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In this Presentation: - Agenda - BPCIA Refresher - FDA Developments - Purple Book, FDA Review of Applications, Draft Guidance, Abbott Petition - The Naming Issue - State Substitution Laws -...more

2/6/2014

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