Mylan has received approval from the US Food and Drug Administration (FDA) for the first biosimilar of Amgen’s Neulasta (pegfilgrastim) in the US, with the Fulphila (pegfilgrastim-jmdb) 6mg/0.6ml injectable biosimilar co-developed with Biocon. Expected to be “the first biosimilar pegfilgrastim available in the US”, Fulphila is set to be launched “in the coming weeks”, Mylan anticipates, with a “suite of patient services” to further support patients and caregivers with treatment.
FDA approval was based on review of evidence that included “extensive structural and functional characterisation, animal study data, human pharmacokinetic...
