FDA approves Fulphila a pegfilgrastim biosimilar for treatment of febrile neutropenia.- Mylan N.V. + Biocon.
Mylan N.V. and Biocon Ltd. announced that the FDA has approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. 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 Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S.
Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment. Fulphila has been approved as a biosimilar without an interchangeable product tag.
Comment:. Coherus BioSciences Inc., has a 3 November 2018 PDUFA date with the FDA for its pegfilgrastim biosimilar. It had received a complete response letter in June 2017.
Comment: The US patents for Neulasta expired in October 2015.
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