FDA hands Novartis the keys to a $5B Amgen franchise
Novartis has bagged an FDA approval for Erelzi (etanercept-szzs), its biosimilar of Enbrel. And now the pharma giant is good to go on every indication Enbrel is marketed for in the U.S. including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.
The approval gives Novartis the keys to a market worth $5 billion a year to Amgen, which tried to block this wide-ranging regulatory OK in the key US market. The fight is likely far from over though. Amgen has moved its rear-guard action to the courts, a strategy which has proven far more effective in blocking this first wave of biosimilars and the discounts they promise.
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