The Friday Podcast

In a historic step, on March 6, 2015 the U.S. Food and Drug Administration (FDA) approved the first ever biosimilar product for the U.S. market.  An abbreviated licensure pathway for biosimilars approval in the US was created in 2010 through the Biologics Price Competition and Innovation Act, which is part of the Affordable Care, but this is the first drug to make it through that process.

Topics in this blog post: Biologics, Biosimilars, FDA, Market Access
About The Author

Vice President, Global Strategic Drug Development and Head of Quintiles Global Biosimilars Unit

Recent thinking: Biosimilars and the need for speed