FDA opens comment on biosimilar user-fee program for 2028 through 2032

The Food and Drug Administration has opened public comment on its proposed recommendations for reauthorising the Biosimilar User Fee Act, the law that lets the agency collect fees from manufacturers to fund its review of biosimilar applications, for fiscal years 2028 through 2032 [s1]. The agency published the notice in the Federal Register on 25 September 2026 and will hold a hybrid public meeting on 26 October 2026, from 9 a.m. to 12 p.m. Eastern Time, at its White Oak Campus in Silver Spring, Maryland, and online over Microsoft Teams [s1].

The current authorisation, known as BsUFA III, expires in September 2027 [s1]. Without new legislation, the FDA says, it will no longer be able to collect the user fees that help fund the review of biosimilar biological product applications [s1]. The proposed package now out for comment would become BsUFA IV.

What a user-fee program is

BsUFA authorises the FDA to assess and collect fees from drug companies that submit marketing applications for certain biosimilar biological products [s1]. Those fees supplement the agency's congressional appropriation and, in the FDA's description, let it hire staff, improve systems and sustain a review process intended to bring biosimilar therapies to patients sooner without compromising safety, efficacy or quality standards [s1]. In exchange for the money, the agency commits to specific performance goals, such as deadlines for acting on applications, which are set out in a negotiated commitment letter.

The program is a recurring, time-limited bargain. BsUFA was first enacted in 2012 under the Food and Drug Administration Safety and Innovation Act for a five-year period, reauthorised as BsUFA II through fiscal 2022 under the FDA Reauthorization Act of 2017, and most recently reauthorised in 2022 under the FDA User Fee Reauthorization Act of 2022, which extended it through fiscal 2027 as BsUFA III [s1]. Each cycle requires fresh legislation.

The process the law requires

Section 744I(f)(5) of the Federal Food, Drug, and Cosmetic Act sets out the steps the FDA must take before Congress acts [s1]. After negotiating with the regulated industry and consulting patient and consumer advocacy groups, the agency must present its recommendations to the relevant congressional committees, publish them in the Federal Register, allow 30 days for written public comment, hold a meeting at which the public may present its views, and then revise the recommendations as necessary [s1]. The 26 October meeting and the comment period satisfy two of those steps.

The FDA said it began the reauthorisation process with an earlier Federal Register notice published on 24 November 2025 [s2] and a public meeting held on 3 December 2025, then conducted negotiations with industry and held monthly consultations with patient and consumer advocacy groups from April 2026 through June 2026 [s1]. Written comments on the proposed recommendations are due by 25 November 2026 [s1].

What the proposed BsUFA IV package would change

The notice describes several proposed enhancements. The FDA proposes to replace the existing supplement categories with two categories tied to either four- or six-month review timelines, to streamline and simplify the review of supplemental applications [s1]. It proposes a structured process and review timeline for "provisional determinations", which cover applications that meet licensure standards but cannot be approved because an exclusivity period protecting the reference product has not yet expired [s1].

Under a proposed "imminent action" provision, the agency could work up to 60 days past an application's goal date to resolve discrete, late-arising issues and avoid otherwise unnecessary provisional determinations or complete-response actions [s1]. A proposed "new target action date" process would have the FDA notify an applicant when it anticipates missing a goal date, set a new internal target and identify the issue causing the delay [s1]. The agency also proposes to publish a biosimilar-specific initial pediatric study plan template for public comment [s1].

Why it matters

Biosimilars are lower-cost competitors to expensive biologic medicines, and the pace and predictability of FDA review shapes how quickly they reach the market and begin to exert downward pressure on prices. The user-fee program is the machinery that funds much of that review. Because the authority lapses in September 2027, the reauthorisation is not optional: either Congress passes new legislation or the agency loses a major source of review funding [s1]. The proposals out for comment are the FDA's and industry's opening position; the final recommendations will be revised after the public meeting and then sent to Congress [s1].

Sources

• [s1] Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments — U.S. Food and Drug Administration / Federal Register, 25 September 2026.
• [s2] Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments (process launch notice) — U.S. Food and Drug Administration / Federal Register, 24 November 2025.