FDA approves first biosimilar to Neulasta
The US Food and Drug Administration has approved Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s (Nasdaq: AMGN) Neulasta(pegfilgrastim).
Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.
The biosimilar was co-developed by Netherlands-incorporated Mylan (Nasdaq: MYL) and India’s Biocon BSE: 532523), with news of the long awaited approval sending Mylan’s share up 5.2% to $40.50 in after-hours trading on Monday, while Amgen fell 1.7% to $182.30.
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