Notice2026-19166
Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document
Primary source
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Published
September 18, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" (Strategy Document). This draft Strategy Document is intended to summarize the discussion that occurred at the FDA public workshop, "Advancing the Development of Interchangeable Products: Identifying Future Needs," held on September 19, 2025, and to describe FDA's future directions to support interchangeable biosimilar products. FDA is issuing this draft Strategy Document to fulfill a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 through 2027 (BsUFA III) to publish a post-workshop draft strategy document for public comment.
Full Text
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<title>Federal Register, Volume 91 Issue 180 (Friday, September 18, 2026)</title>
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[Federal Register Volume 91, Number 180 (Friday, September 18, 2026)]
[Notices]
[Pages 59140-59141]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19166]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2787]
Biosimilar User Fee Act III Future Needs in the Development of
Interchangeable Products Post-Workshop; Draft Strategy Document
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the publication of a draft strategy document titled ``BsUFA III Future
Needs in the Development of Interchangeable Products Post-Workshop
Strategy Document'' (Strategy Document). This draft Strategy Document
is intended to summarize the discussion that occurred at the FDA public
workshop, ``Advancing the Development of Interchangeable Products:
Identifying Future Needs,'' held on September 19, 2025, and to describe
FDA's future directions to support interchangeable biosimilar products.
FDA is issuing this draft Strategy Document to fulfill a commitment FDA
made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment
letter for fiscal years 2023 through 2027 (BsUFA III) to publish a
post-workshop draft strategy document for public comment.
DATES: Submit either electronic or written comments on this draft
Strategy Document by November 17, 2026 to ensure that the Agency
considers your comment on this draft Strategy Document before it begins
work on the final version of the Strategy Document.
ADDRESSES: You may submit either electronic or written comments as
follows:
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 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-2025-N-2787 for ``Biosimilar User Fee Act III Future Needs in the
Development of Interchangeable Products Post-Workshop; Draft Strategy
Document.'' Received comments 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.
<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
[[Page 59141]]
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: Sarah Ikenberry, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1128, Silver Spring, MD 20993-0002, 301-
796-6893, <a href="/cdn-cgi/l/email-protection#145750514639567d7b787b737d7767567d7b677d797d787566675d7a65617d667d7167547270753a7c7c673a737b62"><span class="__cf_email__" data-cfemail="f7b4b3b2a5dab59e989b98909e9484b59e98849e9a9e9b968584be9986829e859e9284b7919396d99f9f84d9909881">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of the draft Strategy Document
titled ``BsUFA III Future Needs in the Development of Interchangeable
Products Post-Workshop Strategy Document.'' In section II.D.3 of 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>), FDA agreed to hold a public scientific
workshop on the development of interchangeable biosimilar products to
help identify future needs (e.g., guidance, research). FDA also agreed
to issue a draft strategy document for public comment outlining the
specific actions FDA will take to facilitate interchangeable biosimilar
product development within 12 months following the public workshop. The
public workshop was held on September 19, 2025 (90 FR 39395), with both
virtual and in-person attendance, and representatives from trade
associations (Association for Accessible Medicines (AAM),
Pharmaceutical Research and Manufacturers of America (PhRMA), and
Biosimilars Forum) provided their perspectives on future needs for
development and adoption of interchangeable biosimilar products. FDA
speakers from the Center for Drug Evaluation and Research discussed
scientific topics related to analytical data considerations, user
interface and human factors considerations, and other considerations to
facilitate development of interchangeable biosimilar products. The
draft Strategy Document summarizes the discussion that occurred during
the workshop as well as comments received in the public docket. The
major themes identified during the workshop and in comments submitted
to the docket included timely communication of new scientific and
policy developments, challenges with user interface development and
human factors analyses, and approaches to interchangeability that
follow the evolving science. Over the last 5 years, the development and
approval of interchangeable biosimilar products have advanced
considerably. FDA's future efforts will focus on continuing to follow
the evolving science, providing educational resources for healthcare
providers and patients, and helping to ensure that stakeholders have
confidence in the safety and effectiveness of interchangeable
biosimilar products.
II. Electronic Access
The draft Strategy Document is available on the FDA web page for
the public workshop at <a href="https://www.fda.gov/industry/fda-public-workshop-future-needs-development-interchangeable-products-09192025#event-information">https://www.fda.gov/industry/fda-public-workshop-future-needs-development-interchangeable-products-09192025#event-information</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19166 Filed 9-17-26; 8:45 am]
BILLING CODE 4164-01-P
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