FDA Accepts Novartis/Sandoz Regulatory Submission for Proposed Biosimilar to Enbrel - Novartis (NYSE:NVS), Amgen (NASDAQ:AMGN)

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Sandoz, a Novartis (NYSE: NVS) company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's (NASDAQ: AMGN) US-licensed Enbrel®* (etanercept) - a tumor necrosis factor alpha (TNF-alpha) inhibitor. 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 including rheumatoid arthritis and psoriasis affecting approx. 1.3 million[1] and 7.5 million[2] people (respectively) in the US.

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