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 fees are intended to expedite the review process of biosimilar products, and are amended on an annual basis to account for inflation and to ensure that the Agency’s needs are being met.
|Fee Category||FY 2017 Fee Rates|
|Applications Requiring Clinical Data||$2,038,100|
|Applications Not Requiring Clinical Data||$1,019,050|
|Supplement Requiring Clinical Data||$1,019,050|
In addition to providing the updated rates, FDA’s notice states the following:
In some situations, the FDA states that it may grant a small business waiver from its first biosimilar biological product application fee. These rates will kick-in on October 1st and will remain in effect until September 30, 2017.
August 7, 2015
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...
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 7, 2015
As amended by the Prescription Drug User Fee Amendments of 2012, The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect fees from sponsors submitting applications...