> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Biosimilar User Fee Rates Set for FY 2023
- URL: https://www.fdaweb.com/biosimilar-user-fee-rates-set-for-fy-2023/
- Published: 2022-10-07T12:00:00.000Z
- Updated: 2026-09-14T18:02:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152924

*Federal Register* notice: FDA is announcing the rates for biosimilar user fees for fiscal year 2023\. They are:

- Applications requiring clinical data: $1,746,745
- Applications not requiring data: $873,373
- Initial biological product development (BPD) fee: $47,325
- Annual BPD: $47,325
- BPD reactivation: $94,650
- Program fee: $304,162

To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-10-07/pdf/2022-21965.pdf?ref=fdaweb.com).