In order to expedite the review process of biosimilar biological products, FDA is authorized to assess and collect fees from sponsors. The fees are collected for various activities related to biosimilar biological product development (BPD), including:
User fee rates are amended on an annual basis to account for inflation and to ensure the needs of the Agency are being met. Rates for fiscal year 2016 are as follows:
Fee Category |
Fee Rates for FY 2016 |
Initial BPD | $237,420 |
Annual BPD | $237,420 |
Reactivation | $474,840 |
Applications: | |
Requiring Clinical Data | $2,374,200 |
Not Requiring Clinical Data | $1,187,100 |
Supplement Requiring Clinical Data | $1,187,100 |
Establishment | $585,200 |
Product | $114,450 |
August 3, 2016
The Biosimilar User Fee Act of 2012 (BsUFA) authorizes the FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development (BPD). These user...
August 8, 2018
On Tuesday, July 31st, FDA released a notice with updated biosimilar user fee rates for fiscal year 2019. The base revenue for FY 2019 is $40,214,000, not adjusted for inflation or operating...
August 2, 2016
The Prescription Drug User Fee Amendments of 2012 (PDUFA V) allows FDA to collect user fees for the review of applications concerning human drug and biological products, the establishments where...