On February 9, 2012, the U.S. Food and Drug Administration (FDA) published its long-awaited biosimilar guidance documents as a follow-up to the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act) that was signed into law by President Obama on March 23, 2010.  The legislation, which was inspired by the 1984 Hatch-Waxman Act establishing a generic pathway for small molecule drugs, provides a new biosimilar pathway for the approval of large molecule (biologic) drugs.
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On February 9, 2012, the U.S. Food and Drug Administration issued the Agency’s first set of three draft guidance documents outlining the framework for how it will evaluate applications for regulatory approval of biosimilar products.  The long-awaited guidances provide the first detailed comments from FDA on the topic.
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