Sandoz' GP2015 'highly similar' to Enbrel, say FDA staffers
A biosimilar version of Pfizer (NYSE: PFE) and Amgen’s (Nasdaq: AMGN) arthritis drug Enbrel (etanercept) is ‘highly similar’ to the reference product, according to US Food and Drug Administration (FDA) staff briefing documents.
Sandoz, the generics and biosimilars division of Swiss pharma giant Novartis (NOVN: VX), is seeking US marketing authorization for GP20915 in a number of conditions including rheumatoid arthritis, psoriasis and psoriatic arthritis.
An FDA committee is due to meet on Wednesday to discuss whether to approve the injection.
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