Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies
Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.
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Mylan's Fulphila Sets Up The US Market For The Next Biosimilar Showdown
Mylan has priced its biosimilar version of pegfilgrastim at a 33% discount to Amgen's WAC for Neulasta, steeper than the 15% discount Pfizer initially offered for Inflectra. The commercial outcome for Fulphila could set the tone for future US biosimilars, which have yet to take off.
Mylan's Fulphila Approval: Lack Of US FDA AdComm May Be A Positive For Biosimilar Industry
The advisory committee route for approving a first biosimilar to a reference product is no longer necessarily the norm, going by FDA's recent approval of Mylan/Biocon's pegfilgrastim-jmdb, which references Amgen’s Neulasta; agency’s view that a meeting was not needed should encourage other biosimilar aspirants.