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Mylan's Fulphila Approval: Lack Of US FDA AdComm May Be A Positive For Biosimilar Industry

Executive Summary

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.

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Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies

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