Biosimilar User Fee Rates for Fiscal Year 2027

BsUFA III also authorizes fees for certain biosimilar biological product applications and for each biosimilar biological product identified in an approved biosimilar biological product application (section 744H(a)(2) and (3) of the FD&C Act). B. Biosimilar Biological Product Program FeeUnder BsUFA III, FDA assesses biosimilar biological product program fees (“program fees”). An applicant in a biosimilar biological product application shall not be assessed more than five program fees for a fiscal year for biosimilar biological products identified in a single biosimilar biological product application (see section 744H(a)(3)(D) of the FD&C Act). These estimates provide information that, when aggregated, allows FDA to set BPD fees (initial BPD fees, annual BPD fees, reactivation fees). Table 7—Fee Schedule for FY 2027 Fee category Fee rates for FY 2027 Initial BPD $10,000 Annual BPD 10,000 Reactivation 20,000 Applications: Requiring Clinical Data 1,124,936 Not Requiring Clinical Data 562,468 Program Fee 195,887V. Fee Payment Options and ProceduresA.