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BIO addresses FDA approval of biosimilar product.

2015-03-10 13:31:09| Industrial Newsroom - All News for Today

BIO issued statement regarding approval by FDA of the first biosimilar product under the pathway created by the Biologics Price Competition and Innovation Act. According to Jim Greenwood, BIO President and CEO, for more than a decade, BIO has called for open, transparent, and science-based dialogue regarding biosimilars. It is unfortunate that the lack of publicly available naming guidance resulted in FDA's assignment of a "placeholder" name for approved biosimilar.

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