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

 
• By Sue Sutter and Anju Ghangurde

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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THE US FDA DECIDED AGAINST THE NEED FOR AN ADCOMM FOR FULPHILA

Mylan NV and Biocon Ltd.'s Fulphila (pegfilgrastim-jmdb), the first biosimilar to Amgen Inc.’s Neulasta (pegfilgrastim) approved in the US, was cleared by the FDA without having to go through the generally expected advisory committee route. That the agency concluded the application did not warrant referral to its external experts could enthuse other biosimilar sponsors, who may be able to save themselves the considerable resources needed to prepare for such public reviews.

Biosimilar pegfilgrastims have had a troubled regulatory journey in the US, with at least four complete response letters (CRLs) issued to date on 351(k) applications that reference Neulasta

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