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PDUFA Fees Push Higher In FY 2024, While Biosimilar Fees Race Downward

 
• By Derrick Gingery

Fiscal year 2024 prescription drug user fees skyrocket in part because of a low application volume in FY 2022, while biosimilar user fees continue to drop due to the program’s healthy operating reserve.

money bag handed over
New drug sponsors will hand over a lot more money with their FDA applications in FY 2024. • Source: Shutterstock

A dramatic decrease in fee-paying drug and biologic applications in fiscal year 2022 helped push prescription drug user fees up nearly 25% for FY 2024.

The US Food and Drug Administration announced the new prescription drug user fees, along with the generic drug,

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