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.
