28 min listen
FDA Guidance on Names for Biologics and Biosimilars and its Implications
FromThe Bio Report
ratings:
Length:
22 minutes
Released:
Sep 10, 2015
Format:
Podcast episode
Description
The U.S. Food and Drug Administration recently released long-awaited draft guidance regarding the naming of biologics, biosimilars, and interchangeable biologics. At the same time the agency released a proposed rule to apply the naming scheme to six current biological products with, or expected to soon have, biosimilar competitors. We spoke to Gillian Woollett, senior vice president with the healthcare business strategy and public policy advisory firm Avalere Health, about the FDA’s actions, their implications, and some potential unintended consequences.
Released:
Sep 10, 2015
Format:
Podcast episode
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