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FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements
2015-04-03 07:01:53| Biotech - Topix.net
Late last week, the U.S. Food and Drug Agency dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their application and information on their manufacturing processes. At issue is the meaning of the term " shall " and whether the information-sharing and advance-notice provisions of the Biologics Price Competition and Innovation Act that a biosimilar applicant "shall providea copy of the application submitted [to FDA]and such other information that describes process or processes used to manufacture the biological product" is a mandatory requirement or an optional action for the biosimilar applicant.
Tags: requirements
citizen
applicant
petition
Category:Biotechnology and Pharmaceuticals