FDA Biosimilar Meetings Offer Chance To Skip Clinical Trials

Law360, New York (April 4, 2013, 7:43 PM EDT) -- The U.S. Food and Drug Administration expects biosimilars makers to participate in exhaustive preapplication meetings with the agency, as detailed in new guidelines last week, but experts say the lengthy process will give sponsors a chance to convince reviewers that they do not need expensive human trials to prove biosimilarity.

The FDA released a draft guidance last week detailing the process for meetings under the biosimilar biological product development program, in which companies developing biosimilars can request a series of meetings with FDA staff. The meetings...
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