For Industry

Biosimilar User Fee Act (BsUFA)

Notice to applicants who owe annual BPD fees for FY 2014:

In accordance with BsUFA, 21 U.S.C. §379j-52(a)(1)(B)(ii), annual biosimilar biological product development fees for FY 2014 are due “on...the first business day after the enactment of an appropriations Act providing for the collection and obligation of [BsUFA] fees for fiscal year 2014.”  Because the Continuing Resolution (an appropriations Act) for fiscal year 2014 was enacted on October 17, 2013, annual biosimilar biological product development fees assessed for fiscal year 2014 are due on October 18, 2013.

Notice to applicants with pending submissions for biosimilars at the time of the government shutdown:

For the biosimilar biological products program, for which carryover user fee funds were not available during the shutdown, the agency plans to extend the existing goal dates by the number of days the government was shut down.  Even so, because of the need to reschedule certain internal meetings or meetings with product sponsors, some biosimilars goal dates may not be met.

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect fees for biosimilar biological products from October 2012 through September 2017.  FDA dedicates these fees to expediting the review process for biosimilar biological products.  Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient.  BsUFA facilitates the development of safe and effective biosimilar products for the American public.


Page Last Updated: 08/08/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.