FDA Announces Biosimilar User Fee Rates for FY 2017

U.S. FDA News

The FDA has announced the rates for biosimilar user fees for the 2017 Fiscal Year:

FY17 BsUFA Fees

Biological Product Development Initial $203,810
Annual $203,810
Application w/Clinical Data $2,038,100
w/o Clinical Data $1,019,050
Supplement w/Clinical Data $1,019,050
Product $97,750
Establishment $512,200
Reactivation $407,620

The biosimilar user fees for a given fiscal year are calculated as a percentage of the fee rate established under the Prescription Drug User Fee Act (PDUFA) for that fiscal year. Interestingly, the rates for FY17 are lower than the current rates:

FY16 BsUFA Fees

Biological Product Development Initial $237,420
Annual $237,420
Application w/Clinical Data $2,374,200
w/o Clinical Data $1,187,100
Supplement w/Clinical Data $1,187,100
Product $114,450
Establishment $585,200
Reactivation $474,840

The new rates will take effect on October 1, 2016.

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