Blog Big Molecule Watch July 28, 2016

FDA Announces Biosimilar User Fee Rates for FY 2017

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.