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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.
- Biosimilar User Fee Rates for Fiscal Year 2015
- Biosimilar User Fee Act of 2012 (Title IV of the Food and Drug Administration Safety and Innovation Act)
- Biosimilar Authorization Performance Goals and Procedures Fiscal Years 2013 through 2017
- FDA User Fees 2012: How Innovation Helps Patients and Jobs
- Statement from HHS Secretary Kathleen Sebelius on the signing of the Food and Drug Administration Safety and Innovation Act
- User Fees: Ensuring a Stronger and Better FDA
U.S. Food and Drug Administration Statement: The impact of Hurricane Sandy on Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) deadlines Fact Sheet: New "Biosimilars" User Fees Will Enhance Americans' Access to Alternatives to Biologic Drugs