# 2025-20654: FDA Seeks Input on Biosimilar Fee Hike for 2028

2025-20654, Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-24, effective The public meeting will be held on December 3, 2025, and electronic or written comments must be submitted by January 2, 2026. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-20654
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-20654
- Title: Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 52967
- Published: 2025-11-24
- Effective: The public meeting will be held on December 3, 2025, and electronic or written comments must be submitted by January 2, 2026.
- Comments close: 2026-01-02
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Seeks Input on Biosimilar Fee Hike for 2028

## Summary

The FDA is gearing up to renew the Biosimilar User Fee Act, which helps fund the review of biosimilar drugs from 2028 to 2032. They’re hosting a public meeting on December 3, 2025, and want your thoughts by January 2, 2026. This affects drug makers and patients by keeping biosimilar reviews speedy and efficient, with fees supporting the process.

## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA begins the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program for FYs 2028 through 2032. These comments will be published and available on FDA's website.

## Effects PRIA read

- Keeps Biosimilar Reviews Funded: benefit, high. The FDA is seeking reauthorization of the Biosimilar User Fee Act for fiscal years 2028 through 2032. The law lets FDA collect user fees so it can hire staff and improve systems to keep biosimilar reviews moving and make biosimilar therapies available to patients sooner; the current authority expir…
- Drug Makers Will Pay User Fees: cost, medium. If reauthorized for FYs 2028 through 2032, BsUFA authorizes FDA to assess and collect fees from drug companies that submit marketing applications for biosimilar biological products. The notice notes the current legislative authority expires in September 2027 and invites input on fee structures and…
- Expedited Reviews and Interchangeability Work: benefit, medium. The current BsUFA (BsUFA III) includes new supplement categories, timelines, and performance goals to expedite review of supplemental biosimilar applications and establishes a regulatory science pilot to advance development of interchangeable biosimilars. Those procedures aim to improve the efficie…

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## Sources
- [2025-20654 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/24/2025-20654/reauthorization-of-the-biosimilar-user-fee-act-public-meeting-request-for-comments)
- [2025-20654 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20654.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-20654 (as of 2026-06-08).