The panel voted 20-0 that GP2015, Novartis’ biosimilar version of Enbrel, was equivalent in safety and efficacy to Thousand Oaks, Calif.-based Amgen’s drug.
Enbrel has been approved to treat a variety of conditions, including multiple types of arthritis and psoriasis. While GP2015 was tested in patients with plaque psoriasis, it would be used to treat the same conditions as Enbrel if approved by the agency.
While the FDA is not compelled to follow the advisory committee’s advice, it typically does.
The panel’s unanimous vote mirrors a decision it made on Tuesday to recommend approval for Amgen’s version of North Chicago, Ill.-based AbbVie’s arthritis drug Humira.
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