Fulphila Clinical Development Timeline
Chronicle of the development and US FDA review of Mylan’s pegfilgrastim-jmdb (MYL-1401H), a biosimilar to Amgen’s Neulasta.
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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.
FDA staff who participated in the review of Mylan’s pegfilrastim-jmdb, the first US-licensed biosimilar to Amgen’s Neulasta.
Posting of final review documents for three biosimilars – Cyltezo, Mvasi and Fulphila – brings to seven the number of licensed biosimilars for which action packages with underlying analytical and clinical data are publicly available. FDA has attributed posting delays to a backlog in the redaction queue but is not prioritizing postings based upon order of approval or commercial availability.