Biosimilar User Fee Revenue Missed Estimates Again In FY 2019, Spending Reduced

US FDA said that total BsUFA obligations also decreased compared to estimates, but maintains optimism about future revenue increases.

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Estimates of future BsUFA revenue indicate substantial increases compared to FY 2019 collections. • Source: Shutterstock

Biosimilar user fee collections missed estimates significantly once again in fiscal year 2019, which forced the US Food and Drug Administration to reduce spending to account for the shortfall.

BsUFA collections were nearly $4.2m less than estimates after fee-paying applications were 22% less than expected, the agency said in...

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