Amgen's $3.9B Neulasta to face U.S. biosim 'in the coming weeks' with Mylan approval

With an FDA approval for Fulphila, the first U.S. biosimilar to Amgen's Neulasta, Mylan will have its chance to launch a biosim to one of the biggest drug targets in the U.S. market.It's good news for Mylan, which sees biosimilars as a rescue from the tough market for typical generic drugs. Not so good for Amgen, which reaped $3.9 billion from Neulasta in the U.S. last year and already faces biosimilar competition for the shorter-acting version, Neupogen. Announcing its FDA approval late Monday, Mylan said it will launch the Neulasta copycat, now dubbed Fulphila, in the coming weeks. The company didn't immediately disclose pricing. A white blood cell booster for cancer patients after chemotherapy, Neulasta brought in $3.9 billion in the U.S. last year, making it the second-largest loss of exclusivity in pharma this year.

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