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Biosimilar User Fee Reboot: Resource Challenges Make FDA Eye New Structure

 
• By Derrick Gingery

Fee rates for biosimilars could be decoupled from new drug user fees in order to provide more predictable revenue stream.

FDA appears increasingly interested in decoupling the biosimilar user fee program from its older sibling for prescription drugs, in part to ensure its revenue stream is more predictable.

Biosimilar application fees now follow those for the Prescription Drug User Fee Act (PDUFA). A 351(k)'s application fee is the same as for an NDA, but BsUFA does already have a distinction – firms developing biosimilars pay annual product development fees to FDA equal to 10% of the NDA fee

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