The Federal Register published FY 2027 user fee rates (here) for the biosimilar program, (known as BsUFA). In an unusual twist for various FDA user fees, the BsUFA fees either stayed constant or went down for FY 2027 relative to the FY 2026 fees.
It is likely the success of the BsUFA program that has caused this mind-bending scenario where the estimated submission of biosimilar applications rises significantly and as a result, the corresponding application and program fees decreased. See the above linked FRN for additional information on how the fees were calculated for FY 2027.
According to the FDA’s current posting (here) announcing the fees, “[T]he FDA User Fee program has transitioned to a new centralized email inbox: FDAUserFees@fda.hhs.gov. Please update your records and use this email address for future user fee communications.”
