Sandoz's Second Biosimilar Application Taken Up By FDA, Copies Amgen's Enbrel

October 2, 2015 at 5:44 PM
FDA has accepted for review Sandoz's second biosimilar application, a biosimilar of Amgen's drug Enbrel, a tumor necrosis factor alpha inhibitor, announced parent company Novartis Friday (Oct.2). Sandoz is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases included rheumatoid arthritis and psoriasis. This is the sixth biosimilar application to be taken up by FDA, following Sandoz's filgrastim product; Celltrion's and Hospira's infliximab product; Apotex's pegfilgrastim...


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