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The fiscal year (FY) 2027 BsUFA annual invoices for annual BPD and/or program fees were emailed to sponsors in the BPD program and applicants with program-fee eligible biosimilar products on August 21, 2026. If you are expecting an invoice and do not receive it, please contact the BsUFA User Fee staff at FDAUserFees@fda.hhs.gov. Payment is due on October 1, 2026.
The FY 2027 BsUFA fee rates were published in the Federal Register (FR) on July 30, 2026. The fee rates for FY 2027 are shown below:
| User Fee Type |
FY 2027
Fee Rates
|
| Biosimilar Biological Product Development (BPD) Fee |
Initial BPD |
$10,000 |
| Annual BPD |
$10,000 |
| Reactivation |
$20,000 |
| Application Fee |
Clinical Data Required |
$1,124,936 |
| Clinical Data Not Required |
$562,468 |
| Program Fee |
$195,887 |
For more information, please see the FR notice available (here).
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