BIO presentation at FDA public meeting on biosimilars

May 14, 2012 8:30 AM

Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval pathway for biosimilar and interchangeable biological products.

The key issues she discussed included: interchangeability; naming and labeling; confidentiality of information; reference product and non-U.S. data; patent certification; transition products; and guidence for the implementation of BPCIA.

The full presentation can be reached from here:

The meeting was held last Friday and the transcripts of the public hearing will be available for review at the Division of Dockets Management and on the internet at approximately 30 days after the public hearing.


Source: Biotechnology Industry Organization (BIO)

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