FDA's Stepwise Approach To Demonstrating Biosimilarity

Law360, New York (February 10, 2012, 5:22 PM EST) -- On Feb. 9, the U.S. Food and Drug Administration issued the agency's first set of draft guidance documents outlining the framework for how it will evaluate applications for regulatory approval of biosimilar products. The long-awaited guidance provide the first detailed comments from FDA on the topic.

The Biologics Price Competition and Innovation Act of 2009 established an abbreviated approval process in the U.S. for obtaining licensure of a biological product considered to be biosimilar to a previously approved biological product ("reference product"). Although the BPCI Act...
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