Notice2025-15572
Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments
Primary source
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Published
August 15, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Advancing the Development of Interchangeable Products: Identifying Future Needs." The purpose of the public workshop is to address a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years (FYs) 2023 through 2027 (BsUFA III) to hold a scientific workshop to discuss and identify future needs (e.g., guidance, research) that, when addressed, may help further advance the development of interchangeable biosimilar products.
Full Text
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<title>Federal Register, Volume 90 Issue 156 (Friday, August 15, 2025)</title>
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[Federal Register Volume 90, Number 156 (Friday, August 15, 2025)]
[Notices]
[Pages 39395-39397]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15572]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2787]
Advancing the Development of Interchangeable Products:
Identifying Future Needs; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Advancing the
Development of Interchangeable Products: Identifying Future Needs.''
The purpose of the public workshop is to address a commitment FDA made
in the Biosimilar User Fee Act (BsUFA) reauthorization commitment
letter for
[[Page 39396]]
fiscal years (FYs) 2023 through 2027 (BsUFA III) to hold a scientific
workshop to discuss and identify future needs (e.g., guidance,
research) that, when addressed, may help further advance the
development of interchangeable biosimilar products.
DATES: The hybrid public workshop will be held on September 19, 2025,
from 9 a.m. to 1 p.m. Eastern Time, and will take place in person and
virtually. Either electronic or written comments on this public
workshop must be submitted by October 19, 2025. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public workshop will be held in person at the FDA White
Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the
Great Room, Silver Spring, MD 20993-0002, and virtually using the
Microsoft Teams platform. In-person 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>.
Entrance for the public workshop participants (non-FDA employees) is
through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to
<a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</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 on October 19, 2025. 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 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 ``Advancing the Development of Interchangeable
Products: Identifying Future Needs; Public Workshop; 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: 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#1d6e7c6f7c7533747678737f786f6f645d7b797c3375756e337a726b"><span class="__cf_email__" data-cfemail="57243625363f793e3c3239353225252e17313336793f3f2479303821">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is hosting a hybrid public workshop entitled ``Advancing the
Development of Interchangeable Products: Identifying Future Needs,'' in
accordance with the commitment in section II.D.3 of the BsUFA III
commitment letter. The purpose of the public workshop is to seek
stakeholder input on potential areas that need to be addressed to
facilitate the development of interchangeable biosimilar products.
Input received during the workshop will inform the development of a
draft strategy document that outlines specific actions FDA will take to
facilitate the development of interchangeable biosimilar products and
that FDA will publish, for public input, within 12 months following the
workshop.
II. Topics for Discussion at the Public Workshop
FDA and industry stakeholders invited by FDA will provide
perspectives on future needs for the development of interchangeable
biosimilar products. Additionally, FDA subject matter experts will
discuss product quality considerations for biosimilars (including
interchangeable biosimilars) and considerations around
interchangeability from the perspective of user interface and human
factor aspects related to delivery devices as well as other
considerations around interchangeability of biological products.
Following speaker presentations, presenters will participate in a
moderated panel
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discussion and question and answer session.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: <a href="https://www.fda.gov/industry/fda-public-workshop-future-needs-development-interchangeable-products-09192025">https://www.fda.gov/industry/fda-public-workshop-future-needs-development-interchangeable-products-09192025</a>. Please
indicate either in-person or virtual attendance and provide complete
contact information for each attendee, including name 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. Persons interested in attending this public
workshop must register by Friday, September 19, 2025, at 9 a.m. Eastern
Time for in-person registration. Virtual attendees can register and
join at any time through the conclusion of the meeting. Early
registration for in-person attendance 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 time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 8:30 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
If you need special accommodations due to a disability, please
contact Sarah Ikenberry, 301-796-6893, <a href="/cdn-cgi/l/email-protection#2d5e4c5f4c4503444648434f485f5f546d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="aeddcfdccfc680c7c5cbc0cccbdcdcd7eec8cacf80c6c6dd80c9c1d8">[email protected]</span></a> no
later than September 12, 2025.
Although FDA verified the website addresses in this document,
please note that websites are subject to change over time.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Dated: August 12, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15572 Filed 8-14-25; 8:45 am]
BILLING CODE 4164-01-P
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