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FDA Posts Biosimilar User Fee Rates


Federal Register Notice: FDA is announcing the rates for biosimilar user fees for fiscal year 2017. Under the Biosimilar User Fee Act of 2012 (BsUFA) the initial and annual biological product development (BPD) fee rates for a fiscal year are equal to 10% of the fee rate established under the Prescription Drug User Fee Act (PDUFA). The rates for an initial BPD are $203,810, for an annual BPD — $203,810; for a reactivation — $407,620; for applications requiring clinical data — $2,038,100; for applications not requiring clinical data — $1,019,050, for a supplement requiring clinical data — $1,019,050; for establishment —$512,200; and for product $97,750. To view this notice, click here.