Notice2025-17290
Classification Categories for Certain Supplements Under Biosimilar User Fee Amendments III; Guidance for Industry; Availability
Primary source
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Published
September 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Classification Categories for Certain Supplements Under BsUFA III." This guidance provides recommendations for applicants on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications for biosimilar and interchangeable biosimilar products under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023.
Full Text
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<title>Federal Register, Volume 90 Issue 172 (Tuesday, September 9, 2025)</title>
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[Federal Register Volume 90, Number 172 (Tuesday, September 9, 2025)]
[Notices]
[Pages 43454-43455]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17290]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-1954]
Classification Categories for Certain Supplements Under
Biosimilar User Fee Amendments III; Guidance for Industry; Availability
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 availability of a final guidance for industry entitled
``Classification Categories for Certain Supplements Under BsUFA III.''
This guidance provides recommendations for applicants on classification
categories A, B, C, D, E, and F for original and resubmitted prior
approval supplements submitted to approved applications for biosimilar
and interchangeable biosimilar products under the Public Health Service
Act (PHS Act). The commitment letter associated with the Biosimilar
User Fee Amendments of 2022 (BsUFA III) sets forth these supplement
classification categories and their associated review performance
goals. This guidance is intended to help applicants identify the
appropriate classification category and review goal date of the
supplement being submitted. This guidance finalizes and replaces the
draft guidance of the same title issued on August 11, 2023.
DATES: The announcement of the guidance is published in the Federal
Register on September 9, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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-2023-D-1954 for ``Classification Categories for Certain Supplements
Under BsUFA III.'' 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, 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Mustafa [Uuml]nl[uuml], Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1139, Silver Spring, MD 20993, 301-796-
3396; or Phillip Kurs, Center for Biologics Evaluation and Research,
Food and Drug Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
entitled ``Classification Categories for Certain Supplements Under
BsUFA III.'' This guidance provides recommendations for applicants and
FDA review staff on classification categories A, B, C, D, E, and F for
original and resubmitted prior approval supplements (hereafter
``supplements'') submitted to approved applications under section
351(k) of the PHS Act (42 U.S.C. 262(k)). These classification
categories pertain to supplements for biosimilar and interchangeable
biosimilar products seeking the following:
<bullet> To update prescribing information and, if applicable, FDA-
approved patient labeling (e.g., Patient Package Insert, Medication
Guide, Instructions for Use) with safety information that has been
updated in the reference product labeling and is applicable to one or
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more indications for which the biosimilar or interchangeable biosimilar
product is licensed.
<bullet> To receive licensure for an additional indication.
<bullet> To remove an approved indication.
<bullet> To receive an initial determination of interchangeability.
Supplements to approved applications under section 351(k) of the
PHS Act that do not meet the criteria under Categories A through F are
outside the scope of this guidance.
This guidance is intended to help applicants identify the
appropriate classification category and review goal date of the
supplement being submitted. Section I.A. of the commitment letter
associated with the BsUFA III sets forth these supplement
classification categories and their associated review performance
goals. The full text of the proposed BsUFA III Commitment Letter can be
found on the Agency's web page ``BsUFA III: Fiscal Years 2023-2027,''
available at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027</a>.
This guidance finalizes the draft guidance entitled
``Classification Categories for Certain Supplements Under BsUFA III''
issued on August 11, 2023 (88 FR 54626). FDA considered comments
received on the draft guidance as the guidance was finalized. Changes
from the draft to the final guidance include clarification that the
guidance does not include recommendations for manufacturing-only
supplements or for all supplements for safety-related updates to the
labeling, clarification that applicants can request reconsideration of
classification category with appropriate justification, and
clarification that a pediatric assessment or amended initial pediatric
study plan may be included in a Category D supplement. In addition,
editorial changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Classification Categories for Certain
Supplements Under BsUFA III.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
OMB under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521). The collections of information pertaining to the Biosimilar User
Fee Program and for the submission of biologics license applications
under section 351(k) of the PHS Act regarding biosimilar product
applications, interchangeable biosimilar product applications, and
supplemental applications have been approved under OMB control number
0910-0718. The collections of information in 21 CFR 201.56 and 201.57
for the submission of labeling have been approved under OMB control
number 0910-0572. The collections of information pertaining to
Medication Guides for prescription human drug and biological products
have been approved under OMB control number 0910-0393. The collections
of information in 21 CFR part 601 for the submission of biologics
license applications, supplemental applications, and Form FDA 356h have
been approved under OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-17290 Filed 9-8-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 9, 2025.
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