Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

Amgen, Inc. has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA 2014 P 1771) on October 29, 2014, requesting that the FDA mandate compliance with the framework for biosimilar applications laid out by the Biologics Price Competition and Innovation Act.

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