BIO statement on first FDA approval of a biosimilar in the US

March 10, 2015 8:40 AM

The Biotechnology Industry Organization issued the following statement regarding the approval by the FDA of the first biosimilar product under the pathway created by the BPCIA.

The following statement may be attributed to Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood:

“For more than a decade, BIO has called for open, transparent and science-based dialogue regarding biosimilars and we played a leading role in the effort, through the Biologics Price Competition and Innovation Act (BPCIA), to establish a pathway for the approval of biosimilars.  We continue to support the BPCIA, and the approval of biosimilars based on appropriate rigorous science.

“It is unfortunate that the lack of publicly available naming guidance resulted in FDA’s assignment of a “placeholder” name for the approved biosimilar.  We continue to urge the Administration to issue guidance promptly on this crucial matter, as well as on other biosimilar related issues.  The publication of draft guidance for stakeholder comment, followed by final guidance that has taken account of that comment, is the best way to ensure that patient safety is prioritized as the FDA moves forward with implementation of this important law.”

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