FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for April 2016

Posted on Tuesday, April 12 2016 at 4:40 pm by -

What’s In a Name? FDA Releases Draft Guidance on Biosimilar Labeling

By: Carolina M. Wirth and Jennifer Giordano-Coltart, Ph.D.

The Food and Drug Administration (FDA)’s long-awaited draft guidance (Draft Guidance) on biosimilar product labeling was finally issued on March 31, 2016.  The Draft Guidance addresses product labeling requirements for biosimilar products approved under Section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. § 262(k)), referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCIA). 
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