Notice2025-20654
Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 224 (Monday, November 24, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 224 (Monday, November 24, 2025)]
[Notices]
[Pages 52967-52969]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20654]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3326]
Reauthorization of the Biosimilar User Fee Act; Public Meeting;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: The public meeting will be held on December 3, 2025, from 9 a.m.
to 12 p.m. Eastern Time, and will take place in person and virtually.
Either electronic or written comments on this public meeting must be
submitted by January 2, 2026. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public meeting will be held in-person at the FDA White
Oak Campus, 10903 New Hampshire Ave., Building Conference Center, the
White Oak Great Room, Silver Spring, MD 20993-0002 and virtually using
the Microsoft Teams platform. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. Participants must be REAL
ID compliant to access Federal facilities. For additional information
regarding REAL ID, refer to <a href="https://www.dhs.gov/real-id/real-id-faqs">https://www.dhs.gov/real-id/real-id-faqs</a>.
For security and parking information, please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a> and <a href="https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map">https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map</a>. Any
changes to the public meeting location and remote information, as
appropriate, will be posted to <a href="https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025">https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025</a>.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a>
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of January 2, 2026. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or
[[Page 52968]]
confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-3326 for ``Reauthorization of the Biosimilar User Fee Act;
Public Meeting; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Thamar Bailey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32 Rm. 4103, Silver Spring, MD 20993-0002, 301-
796-6645, <a href="/cdn-cgi/l/email-protection#8ccedfd9cacddee9edf9f8e4e3fee5f6edf8e5e3e2cceae8eda2e4e4ffa2ebe3fa"><span class="__cf_email__" data-cfemail="efadbcbaa9aebd8a8e9a9b87809d86958e9b868081af898b8ec187879cc1888099">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a hybrid public meeting to begin the
reauthorization process for BsUFA. The authority to collect user fees
under BsUFA expires in September 2027. Without new legislation, FDA
will no longer be able to collect user fees for future FYs to fund the
biosimilar biological product review process. Before FDA begins
negotiations with the regulated industry on BsUFA reauthorization, the
Agency is holding the public meeting announced in this notice, at which
the public may present their views on reauthorization, including any
suggestions for changes to the performance goals referred to in the
``Biosimilar Biological Product Reauthorization Performance Goals and
Procedures Fiscal Years 2023 through 2027'' (the BsUFA III Commitment
Letter) (available at <a href="https://www.fda.gov/media/152279/download?attachment">https://www.fda.gov/media/152279/download?attachment</a>). In addition, FDA will provide a period of 30 days
after the public meeting for the public to submit written comments.
The purpose of this public meeting is to hear the public's views on
BsUFA as we consider elements to propose, update, or discontinue in the
next BsUFA. In addition to any other relevant information the public
would like to share, the FDA is interested in responses to the
following four general questions:
<bullet> What is your assessment of the overall performance of the
current reauthorization of BsUFA FYs 2023 through 2027 to date?
<bullet> What current elements of BsUFA should be retained,
changed, or discontinued to further strengthen and improve the program?
<bullet> What new elements, if any, should FDA consider adding to
the program to enhance the efficiency and effectiveness of the
biosimilar biological product review process?
<bullet> What changes, if any, could be made to the current fee
structures and amounts to better advance the goals of the agreement,
including facilitating product development and timely access for
consumers?
II. What is BsUFA and what does it do?
FDA provides the following information to help potential meeting
participants better understand the history and evolution of BsUFA and
its status. BsUFA is a law that authorizes FDA to assess and collect
fees from drug companies that submit marketing applications for
biosimilar biological products. BsUFA was originally enacted in 2012
under the Food and Drug Administration Safety and Innovation Act (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 (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. 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
[[Page 52969]]
guidances, BsUFA user fee rates, performance reports, and financial
reports: <a href="https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments">https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments</a>.
The current authorization of BsUFA (BsUFA III) introduces new
supplement categories, timelines, and performance goals to expedite the
review of supplemental biosimilar biological product applications. It
establishes 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
modifies two meeting types (Biosimilar Initial Advisory and Type 4),
creates a new meeting type (Type 2a), and provides a new follow up
opportunity after meetings or written-response-only communication. The
agreement introduces 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 includes additional commitments to advance
interchangeable biosimilar biological product development through
publishing foundational guidances and stakeholder engagement. BsUFA III
includes 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 builds on 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 commits 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
the FDA website at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/completed-bsufa-iii-deliverables">https://www.fda.gov/industry/biosimilar-user-fee-amendments/completed-bsufa-iii-deliverables</a>.
III. Public Meeting Information
A. Purpose and Scope of the Meeting
The public meeting's format will include presentations by FDA and
other interested parties, which may include scientific and academic
experts, healthcare professionals, representatives of patient and
consumer advocacy groups, the biosimilar biological product industry,
and the general public. FDA policy issues outside of the BsUFA program
are beyond the scope of these reauthorization discussions. Accordingly,
comments should focus on process enhancements and funding issues, and
not on policy issues outside of the BsUFA program scope. A draft agenda
and other background information for the public meeting will be posted
at: <a href="https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025">https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025</a>.
B. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following web page: <a href="https://bsufareauthorization.eventbrite.com/">https://bsufareauthorization.eventbrite.com/</a>.
Please provide complete contact information for each attendee,
including attendance format (in-person or virtual), name, title,
affiliation, and email.
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 organization. Registrants will receive confirmation when they have
been accepted. If you need special accommodations due to a disability,
please email <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="9cdeefc9daddcef9fde9e8f4f3eef5e6fde8f5f3f2dcfaf8fdb2f4f4efb2fbf3ea">[email protected]</a> no later than November
21, 2025, 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 presentations 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 November 26, 2025. All requests to make a
public comment during the meeting must be received via registration by
November 21, 2025, 11:59 p.m. Eastern Time. No commercial or
promotional material will be permitted to be presented or distributed
at the public meeting.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. The webcast link for this public meeting can be found
here: <a href="https://teams.microsoft.com/l/meetup-join/19%3ameeting_MTVlZjIxZWEtZWU4YS00M2U1LWJjZjYtMjMwMjYzOTNhMTFh%40thread.v2/0?context=%7b%22Tid%22%3a%227d2fdb41-339c-4257-87f2-a665730b31fc%22%2c%22Oid%22%3a%228bdc93ee-b39c-48de-bb43-4e71da4f3d52%22%7d">https://teams.microsoft.com/l/meetup-join/19%3ameeting_MTVlZjIxZWEtZWU4YS00M2U1LWJjZjYtMjMwMjYzOTNhMTFh%40thread.v2/0?context=%7b%22Tid%22%3a%227d2fdb41-339c-4257-87f2-a665730b31fc%22%2c%22Oid%22%3a%228bdc93ee-b39c-48de-bb43-4e71da4f3d52%22%7d</a>.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at <a href="https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025">https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025</a>.
Notice of this meeting is given pursuant to 21 U.S.C 379j-53.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-20654 Filed 11-21-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 24, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.