ARTICLE | Company News

FDA accepts Sandoz BLA for Enbrel biosimilar

October 2, 2015 11:57 PM UTC

The Sandoz unit of Novartis AG (NYSE:NVS;SIX:NOVN) said FDA accepted for filing a BLA for biosimilar etanercept ( GP2015). The company is pursuing approval in all indications approved for reference product Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN). Novartis spokesperson Eric Althoff declined to disclose an FDA user action date for the tumor necrosis factor (TNF) alpha inhibitor.

Enbrel is approved to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. Althoff would not name the indications in which Sandoz had conducted clinical trials of the biosimilar, but said "psoriasis is the most sensitive indication for the evaluation of biosimilarity." ...