Drugmakers Spar Over Clinical Trial Rules For Biosimilars

Law360, New York (April 17, 2012, 7:01 PM EDT) -- Generics makers urged the U.S. Food and Drug Administration on Monday not to require clinical trials for proposed biosimilars, claiming there is “no scientific basis” for FDA concerns about immune reactions, while big pharma groups demanded human trials for all biosimilars.

Comments were due Monday on the FDA's proposed guidelines for the approval of biosimilars, or generic biologic drugs, and representatives of the pharmaceutical and biologics industries, generics makers, patient advocates, pharmacists, lawmakers and the government of South Korea all weighed in.

The FDA released draft...
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