Issue Date: July 18, 2016
Two biosimilars get U.S. panel’s nod
An FDA advisory panel voted unanimously last week to recommend that the agency approve biosimilar versions of two multi-billion-dollar-selling arthritis drugs. FDA often accepts such panels’ recommendations. The panel voted 20-0 in support of Sandoz’s version of Enbrel, an Amgen drug that is used to treat arthritis and psoriasis. The panel also voted 26-0 in favor of approving Amgen’s version of the AbbVie arthritis drug Humira. In the latter case, AbbVie claims to have patents that protect Humira from competition until at least 2022.
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