SUPPLEMENTARY INFORMATION:

I. Introduction

FDA is announcing a hybrid public meeting to begin the reauthorization process for BsUFA, the legislation that authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current authorization of the program (BsUFA III) expires in ( printed page 60964) September 2027. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to help fund the process for the review of biosimilar biological product applications. Section 744I(f)(5) of the FD&C Act (21 U.S.C. 379j-53(f)(5)) requires that after FDA holds negotiations with regulated industry and periodic consultations with patient and consumer advocacy groups, we do the following: (1) present the recommendations to the relevant Congressional committees, (2) publish the recommendations in the Federal Register , (3) provide a period of 30 days for the public to provide written comments on the recommendations, (4) hold a meeting at which the public may present its views, and (5) after consideration of public views and comments, revise the recommendations as necessary.

This notice, the comment period, and the public meeting described in this notice help satisfy these requirements. After the public meeting, we will revise the recommendations as necessary and present our proposed recommendations to the relevant Congressional committees. The purpose of the meeting is to hear the public's views on the proposed recommendations for the reauthorized program (BsUFA IV). The following information is provided to help potential meeting participants better understand the history and evolution of the BsUFA program and the status of the proposed BsUFA IV recommendations.

II. What is BsUFA and what does it do?

The following information is provided to help potential meeting participants better understand the history and evolution of the BsUFA program and its status. BsUFA is a law that authorizes FDA to assess and collect fees from drug companies that submit marketing applications for certain biosimilar biological products. BsUFA was originally enacted in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) for a 5-year period. Congress reauthorized BsUFA (BsUFA II) for an additional 5 years, through FY 2022, under the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52). BsUFA was most recently reauthorized in 2022 under Title IV of the FDA User Fee Reauthorization Act of 2022 (FDAUFRA) (Pub. L. 117-180), extending the program through FY 2027 (BsUFA III).

BsUFA's intent is to provide additional revenues so that FDA can hire staff, improve systems, and continue a well-managed biosimilar biological product review process to make biosimilar biological product therapies available to patients sooner without compromising review quality or FDA's high standards for safety, efficacy, and quality. As part of FDA's agreements with industry during prior BsUFA authorizations, the Agency agreed to certain performance and procedural goals and other commitments, which are documented on FDA's website. The goals apply to the process for the review of biosimilar biological product applications, including biosimilar biological product development meetings, review of applications and supplements, and other review activities. FDA's website provides more information about BsUFA, including the statutory text of FDAUFRA, the BsUFA III Commitment Letter, key Federal Register documents, BsUFA-related guidances, BsUFA user fee rates, performance reports, and financial reports available at www.fda.gov/​industry/​fda-user-fee-programs/​biosimilar-user-fee-amendments.

The current authorization of BsUFA (BsUFA III) introduced new supplement categories, timelines, and performance goals to expedite the review of supplemental biosimilar biological product applications. It established new procedures and performance goals for the review of use-related risk analysis and human factors protocol submissions, aimed at advancing the development of biosimilar biological product-device combination products. To improve overall meeting management, BsUFA III modified two meeting types (Biosimilar Initial Advisory and Type 4), created a new meeting type (Type 2a), and provided a new follow-up opportunity after meetings or written-response-only communication. The agreement introduced a regulatory science pilot program focused on advancing the development of interchangeable biosimilar biological products and improving the efficiency of biosimilar biological product development. It included additional commitments to advance interchangeable biosimilar biological product development through publishing foundational guidances and stakeholder engagement. BsUFA III included commitments to promote best practices in communication between FDA and sponsors during application reviews, enhance inspection communication, and provide guidance on alternative tools to assess manufacturing facilities.

BsUFA III built upon the financial enhancements included in BsUFA II to ensure optimal use of user fee resources, transparency around the use of financial resources, and management of the carryover balance. The agreement committed FDA to leveraging cloud technology to modernize the Electronic Submissions Gateway and to establish and progress a data and technology modernization strategy. A comprehensive list of the deliverables developed to meet BsUFA III commitments is available on FDA's website at www.fda.gov/​industry/​biosimilar-user-fee-amendments/​completed-bsufa-iii-deliverables.

III. Proposed BsUFA IV Recommendations

In preparing the proposed recommendations to Congress for BsUFA reauthorization, FDA conducted discussions with the regulated industry and consulted with patient and consumer advocacy groups, as required by law. We began the BsUFA reauthorization process by publishing a notice in the Federal Register (90 FR 52967, November 24, 2025) requesting public input on the reauthorization and announcing a public meeting that was held on December 3, 2025. The meeting included a presentation by FDA, remarks from representatives of regulated industry, and public comments from representatives of a number of different stakeholder groups, including patient advocates, consumer advocacy groups, health care professionals, and academic researchers. The materials from the meeting, including a transcript and webcast recording, can be found at www.fda.gov/​industry/​public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025.

Following the December 2025 public meeting, FDA conducted negotiations with the regulated industry and held monthly consultations with patient and consumer advocacy groups from April 2026 through June 2026. As directed by Congress, FDA posted minutes of these meetings on its web page, BsUFA IV: Fiscal Years 2028-2032, available at www.fda.gov/​industry/​biosimilar-user-fee-amendments/​bsufa-iv-fiscal-years-2028-2032.

The proposed enhancements for BsUFA IV address many of the priorities identified by public stakeholders, the regulated industry, and FDA. The proposed enhancements modify aspects of the program to match advances in science and changes in the industry, establish new processes to increase efficiency and enhance communication, advance a lifecycle approach to addressing manufacturing issues, and enhance regulatory and financial ( printed page 60965) transparency. Across the commitment letter, FDA proposes to remove one-time commitments completed under BsUFA III and streamline the text where possible. The full text of the proposed BsUFA IV Commitment Letter can be found on the Agency's web page, BsUFA IV: Fiscal Years 2028-2032, available at www.fda.gov/​industry/​biosimilar-user-fee-amendments/​bsufa-iv-fiscal-years-2028-2032. Each significant new or modified enhancement is described briefly below.

A. Original and Resubmitted Supplemental Biosimilar Biological Product Applications

To streamline and simplify review, FDA proposes to modify the supplement categories and timelines. FDA proposes to replace the BsUFA III supplement categories with two categories that correspond with either 4- or 6-month review timelines. FDA also proposes to issue guidance and/or a manual of policies and procedures on (1) post-approval submissions to 351(k) applications that seek to make labeling changes to conform to changes in reference product labeling and (2) submissions for unbranded 351(k) application labeling. These enhancements are described in section I.A.2 of the proposed BsUFA IV Commitment Letter.

B. Provisional Determinations

To facilitate Agency action on biosimilar biological applications upon the expiration of applicable exclusivity periods, FDA proposes to establish a structured process and review timeline for approval requests submitted for applications in a provisional determination status, which refers to applications that otherwise meet applicable licensure standards but cannot be approved due to an unexpired period of exclusivity. FDA also proposes to issue guidance or a manual of policies and procedures on the provisional determination process. These enhancements are described in section I.A.6. of the proposed BsUFA IV Commitment Letter.

C. Imminent Action

To promote efficient review, FDA proposes to enable the Agency to work 60 days past an application goal date to address discrete, late-arising, resolvable issues to help avoid otherwise unnecessary provisional determinations and complete response actions. This enhancement is described in section I.A.7. of the proposed BsUFA IV Commitment Letter.

D. New Target Action Date

To enhance communication with applicants, FDA proposes to establish a process under which the Agency would notify the applicant of an anticipated missed biologics license application (BLA) or supplement goal date, establish a new internal target action date, and identify the issue(s) responsible for the delay. If the new target action date is not met, the Agency would contact the applicant and provide an update on the issue causing delay and the estimated timeline for action, when possible. These enhancements are described in section I.A.8. of the proposed BsUFA IV Commitment Letter.

E. Initial Pediatric Study Plan

To enhance the efficiency of initial pediatric study plan (iPSP) submissions, FDA proposes to publish a biosimilar-specific iPSP template and make it available for public comment. FDA proposes to finalize the template following consideration of public comments. FDA also proposes to issue guidance addressing pediatric study plans for biosimilar products and how biosimilar applicants can meet applicable Pediatric Research Equity Act (PREA) requirements. These enhancements are described in section I.C. of the proposed BsUFA IV Commitment Letter.

F. Multi-Dose Pharmacokinetic and/or Pharmacodynamic Study and Comparative Efficacy Study Protocol Review

To help ensure applicants receive feedback on critical questions prior to study initiation, FDA proposes to implement a process for prioritizing review of multi-dose pharmacokinetic and/or pharmacodynamic study or comparative efficacy study (CES) protocols. FDA proposes to update relevant manuals of policies and procedures and standard operating policies and procedures describing processes and timelines for protocol review to account for this enhancement. This enhancement is described in section I.H. of the proposed BsUFA IV Commitment Letter.

G. Meeting Management

To improve overall meeting management, FDA proposes three enhancements: (1) eliminating the biosimilar initial advisory (BIA) meeting; (2) providing sponsors with the option to request a written response only (WRO) for all BsUFA meeting types; and (3) allowing applicants to use the follow-up opportunity to seek clarification of FDA's advice following a meeting, a WRO, or a correspondence that responds to a sponsor's meeting question. Additionally, FDA proposes revising the biosimilar biological product development (BPD) Type 2b meeting description. This update replaces the BIA meeting with the Type 2b meeting as a sponsor's initial interaction with FDA to discuss a proposed development program. These enhancements are described in section I.I. of the proposed BsUFA IV Commitment Letter.

H. Combination Products

To support the development of biosimilar biological-device combination products, FDA proposes to establish human factors (HF) protocol review goals and issue guidance on alternative approaches to comparative use HF studies. FDA also proposes expanding the BPD Type 2b meeting description to allow sponsors to request a review of use-related risk analysis, comparative analysis, or HF study protocols. These enhancements are described in section I.J. of the proposed BsUFA IV Commitment Letter.

I. Advancing Chemistry, Manufacturing, and Controls Facility Assessment: A Risk-Based Lifecycle Approach

To support the timely development and availability of biosimilar products, FDA proposes to introduce a risk-based lifecycle approach to identifying and addressing manufacturing facility deficiencies. This proposed BsUFA IV chemistry, manufacturing, and controls (CMC) facility lifecycle program is designed to facilitate a proactive approach to addressing manufacturing facility deficiencies through new and enhanced engagement mechanisms between FDA and the regulated industry that may happen before, during, and after an application review cycle. The program introduces a new option for a single CMC facility pre-submission meeting to discuss manufacturing facilities for a proposed application to facilitate readiness before a facility evaluation and inspection. The program also introduces a new post-pre-license inspection (PLI) meeting, when needed, to discuss inspection findings that may impact application approval and corrective actions that may address identified approvability issues. In addition, the program introduces a CMC facility post-action meeting for applications that receive a complete response due in part to manufacturing facility deficiencies. This meeting provides an opportunity to discuss and understand the deficiencies that should be corrected before the application can be approved. FDA proposes to issue guidance describing the implementation ( printed page 60966) of the facility lifecycle program, as well as conduct a third-party assessment and associated public workshop to assess the program's effectiveness and its impact on facility-issue driven complete responses. These enhancements are described in section I.K. of the proposed BsUFA IV Commitment Letter.

J. BsUFA Regulatory Science Pilot Program

Given the goals for the BsUFA regulatory science pilot program were met, FDA proposes sunsetting the program at the end of BsUFA III. If the Agency conducts regulatory science research using BsUFA operating funds during BsUFA IV, FDA proposes the Agency would notify industry and make the research results publicly available, as appropriate. These enhancements are described in section I.L. of the proposed BsUFA IV Commitment Letter.

K. BLA Revocation and Reissuance

To facilitate the transfer of 351(k) BLA(s) between applicants, FDA proposes establishing a 180-day timeline for revoking and reissuing licenses following the receipt of a complete transfer request. The proposed 180-day timeline does not apply in instances when (1) transfers include BLAs regulated by both the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research or (2) the BLA has outstanding facility issues. This enhancement is described in section I.M. of the proposed BsUFA IV Commitment Letter.

L. Assessment of BsUFA Review Program for Pre-Investigational New Drug Applications, Investigational New Drug Applications, and BLAs

To understand and enhance the efficiency of the biosimilar development and regulatory review program, FDA proposes a third-party assessment of review processes, outcomes, and communications between FDA and sponsors during first cycle review. This assessment will help FDA and regulated industry understand challenges and best practices and provide recommendations to help FDA and sponsors (1) limit first cycle complete responses (for applications that are ultimately approvable) and missed goal dates; (2) increase the effectiveness and efficiency of key review processes, communications, and materials; and (3) assess the use of imminent action, new target action dates, and review clock extensions. This enhancement is described in section I.N. of the proposed BsUFA IV Commitment Letter.

M. Continued Enhancement of User Fee Resource Management

FDA will build on the financial enhancements included in prior authorization cycles to ensure optimal use of user fee resources and the alignment of staff to workload through the continued operation of the Agency's resource capacity planning capability. FDA will also continue activities to promote transparency of the use of financial resources in support of the BsUFA program through publication of a 5-year financial plan (along with annual updates). FDA proposes to update the topics included in the financial plan, as well as in the annual Financial Report submitted to Congress. FDA proposes to offer annual technical staff meetings with regulated industry to support the transparency and understanding of BsUFA program finances, and to publish minutes from these meetings on its public website. These enhancements are described in section II of the proposed BsUFA IV Commitment Letter.

N. Enhancements to Fee Mechanisms

While the proposed statutory framework for setting the annual revenue amount is generally consistent with the current authorization, some updates are proposed for BsUFA IV. The updates include the discontinuation of the Strategic Hiring and Retention Adjustment, limits on the use of the Capacity Planning Adjustment, and a reduction in the maximum operating reserve.

BsUFA IV proposes a personnel compensation and benefits (PC&B) set-aside. This PC&B set-aside would ensure that FDA will reserve the funding needed to restaff the BsUFA program at a level consistent with fiscal year 2025, with appropriate adjustments for terminated staff and those intended to be transferred to Shared Services. The PC&B set-aside would ensure that the funds that are set aside will only be used for purposes relating to the hiring and retaining of staff for the review of biosimilar biological product applications. Until FDA's BsUFA-fee- funded PC&B spend exceeds the amount established as the PC&B target amount, the Capacity Planning Adjustment would be unavailable. FDA proposes to redirect existing resources to fund enhancements for BsUFA and restaff the BsUFA program in targeted areas.

The BsUFA IV agreement proposes fee structure changes. BsUFA IV would eliminate the initial, annual, and reactivation BPD fees. For sponsors that intend to submit more than one BLA that contains substantially the same information about the drug substance, BsUFA IV would also introduce a tiered application fee to incentivize such sponsors to submit the BLAs at the same time. This simultaneous filing structure allows the Agency to realize efficiencies in review workload. The proposed tiered application fee structure establishes: (1) a full application fee without the current statutory fee differentiation based on clinical data; (2) no fee for BLAs containing substantially the same information about the drug substance (or drug substances in the case of either a fixed-combination product or a combination product) as another BLA submitted by the same sponsor on the same day; and (3) a half application fee for BLAs containing substantially the same information about the drug substance (or drug substances in the case of either a fixed-combination product or a combination product) as another BLA submitted by the same sponsor on a prior day. BsUFA IV also proposes to update the eligibility for the small business waiver to only companies based in the United States ( i.e., applicants created or organized under the laws of any State).

IV. Public Meeting Information

A. Purpose and Scope of the Meeting

The meeting will include presentations by FDA and panels with FDA and regulated industry representatives to present and discuss the agreed-upon proposed enhancements. The meeting will also provide an opportunity for other interested parties, including scientific and academic experts, healthcare professionals, representatives of patient and consumer advocacy groups, and the general public, to verbally comment on the proposed enhancements. A draft agenda and other background information for the public meeting will be posted at: www.fda.gov/​industry/​biosimilar-user-fee-amendments/​bsufa-iv-fiscal-years-2028-2032.

B. Participating in the Public Meeting

Registration: Information about how to register for the public meeting is available on FDA's web page for this public meeting: www.fda.gov/​industry/​biosimilar-user-fee-amendments/​bsufa-iv-fiscal-years-2028-2032. Registration is free for both in-person and virtual attendance. In-person attendance is based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each ( printed page 60967) organization. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please email BsUFAReauthorization@fda.hhs.gov no later than October 16, 2026, 11:59 p.m. Eastern Time.

Opportunity for Public Comment: During online registration, you may indicate if you wish to make a public comment. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their public comments and request time jointly. Following the close of registration, we will determine the amount of time allotted to each commenter and the approximate time each comment is to begin, and will notify participants by October 19, 2026. All requests to make a public comment during the meeting must be received via registration by October 16, 2026, 11:59 p.m. Eastern Time. Onsite registration for public comments on the day of the public meeting will not be provided. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

Streaming Webcast of the Public Meeting: When available, the virtual link to the hybrid public meeting will be posted on FDA's public web page at www.fda.gov/​industry/​biosimilar-user-fee-amendments/​bsufa-iv-fiscal-years-2028-2032. FDA will also distribute the link via email to registered attendees.

Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript will also be available on FDA's public web page at www.fda.gov/​industry/​biosimilar-user-fee-amendments/​bsufa-iv-fiscal-years-2028-2032.

91 FR 60962