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BIO Statement on First FDA Approval of a Biosimilar Product

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Washington, D.C. (March 6, 2015) &ndash; The Biotechnology Industry Organization (BIO) issued the following statement today regarding the approval by the Food and Drug Administration (FDA) of the first biosimilar product under the pathway created by the Biologics Price Competition and Innovation Act (BPCIA).</p>

Washington, D.C. (March 6, 2015) – The Biotechnology Industry Organization (BIO) issued the following statement today regarding the approval by the Food and Drug Administration (FDA) of the first biosimilar product under the pathway created by the Biologics Price Competition and Innovation Act (BPCIA).

The following statement may be attributed to 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 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  The publication of draft guidance for stakeholder comment, followed by final guidance that has taken account of that comment, is the best way to ensure that patient safety is prioritized as the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."
 

Upcoming BIO Events 

BIO-Europe Spring
March 9-11, 2015
Paris, France

BIO Asia International Conference
March 24-25, 2015
Tokyo, Japan

BioEquity Europe
May 19-20, 2015
Vienna, Austria

BIO International Convention
June 15-18, 2015
Philadelphia, PA

World Congress on Industrial Biotechnology
July 19-22, 2015
Montréal, Canada

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