BASEL (dpa-AFX) - Sandoz, a Novartis company, announced the US FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Enbrel, a tumor necrosis factor alpha (TNF-alpha) inhibitor. This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway.
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.
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