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Biosimilar User Fee Collections Drop Well Below Estimates, But US FDA Not Worried

 
• By Derrick Gingery

The agency hopes application volume increases, but warns the biosimilar user fee revenue will remain volatile.

FDA entrance sign 2016
Estimates for PDUFA and GDUFA were much closer to actual cash collections.

The US Food and Drug Administration's biosimilar user fee program booked a substantial loss in fiscal year 2018 compared to estimates, but the agency is not worried about its ongoing health.

Cash collections were estimated to be $40.2m that year, but the agency only received $29.2m, according to program financial data discussed 7 June during an FDA public meeting on user fee program financial transparency and efficiency

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