Notice2025-22427
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability
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Published
December 10, 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 "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers." The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). This guidance finalizes the revised draft guidance of the same title issued on April 25, 2024.
Full Text
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<title>Federal Register, Volume 90 Issue 235 (Wednesday, December 10, 2025)</title>
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[Federal Register Volume 90, Number 235 (Wednesday, December 10, 2025)]
[Notices]
[Pages 57203-57205]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22427]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-5473]
Promotional Labeling and Advertising Considerations for
Prescription Biological Reference Products, Biosimilar Products, and
Interchangeable Biosimilar Products: Questions and Answers; 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
[[Page 57204]]
``Promotional Labeling and Advertising Considerations for Prescription
Biological Reference Products, Biosimilar Products, and Interchangeable
Biosimilar Products: Questions and Answers.'' The guidance addresses
questions that manufacturers, packers, distributors, and their
representatives (firms) may have when developing FDA-regulated
promotional labeling and advertisements (promotional communications)
for prescription reference products, biosimilar products, and
interchangeable biosimilar products licensed under the Public Health
Service Act (PHS Act). This guidance finalizes the revised draft
guidance of the same title issued on April 25, 2024.
DATES: The announcement of the guidance is published in the Federal
Register on December 10, 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-2019-D-5473 for ``Promotional Labeling and Advertising
Considerations for Prescription Biological Reference Products,
Biosimilar Products, and Interchangeable Biosimilar Products: Questions
and Answers.'' 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: Twyla Mosey, Office of Prescription
Drug Promotion, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver
Spring, MD 20993-0002, 301-796-1200, <a href="/cdn-cgi/l/email-protection#23606766710e6c7367730e71736e634547420d4b4b500d444c55"><span class="__cf_email__" data-cfemail="6f2c2b2a3d42203f2b3f423d3f222f090b0e4107071c41080019">[email protected]</span></a>; 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 guidance for industry
entitled ``Promotional Labeling and Advertising Considerations for
Prescription Biological Reference Products, Biosimilar Products, and
Interchangeable Biosimilar Products: Questions and Answers.'' This
guidance addresses questions firms may have when developing FDA-
regulated promotional communications for prescription reference
products licensed under section 351(a) of the PHS Act (42 U.S.C.
262(a)) and prescription biosimilar products, including interchangeable
biosimilar products, licensed under section 351(k) of the PHS Act.
Section 351(k) of the PHS Act provides an abbreviated licensure
pathway for biological products shown to be biosimilar to or
interchangeable with an FDA-licensed reference product. Section 351(i)
of the PHS Act defines biosimilarity to mean ``that the biological
product is highly similar to the reference product notwithstanding
minor differences in clinically inactive components'' and that ``there
are no clinically meaningful differences between the biological product
and the reference product in terms of the safety, purity, and potency
of the product.'' To meet the standard for interchangeability, an
applicant must provide sufficient information to demonstrate
biosimilarity and also to demonstrate that the biological product can
be
[[Page 57205]]
expected to produce the same clinical result as the reference product
in any given patient and, if the biological product is administered
more than once to an individual, the risk in terms of safety or
diminished efficacy of alternating or switching between the use of the
biological product and the reference product is not greater than the
risk of using the reference product without such alternation or switch
(section 351(k)(4) of the PHS Act). Interchangeable biosimilar products
may be substituted for the reference product without the intervention
of the prescribing healthcare provider (section 351(i)(3) of the PHS
Act). Decisions regarding pharmacy-level substitution are subject to
State pharmacy law.
The guidance discusses considerations for presenting data and
information about reference products or biosimilar products, including
interchangeable biosimilar products, in promotional communications to
help ensure that they are accurate, truthful, and non-misleading. The
guidance includes information about general requirements for the
content of FDA-regulated promotional communications that apply to
reference products and biosimilar products and includes more specific
considerations for developing these promotional communications for
reference products and biosimilar products, such as:
<bullet> Identifying reference products and biosimilar products
<bullet> Presenting information from the studies conducted to support
licensure of the reference product when the information is included in
the FDA-approved labeling of both the reference product and the
biosimilar product
<bullet> Presenting data or information for a biosimilar product
related to the safety or effectiveness of the biosimilar product that
is not included in the FDA-approved labeling but is consistent with the
FDA-approved labeling for that product
<bullet> Comparing a biosimilar product and its reference product
<bullet> Submitting promotional communications to FDA
The guidance also provides examples to illustrate some of the
considerations outlined in the guidance.
This guidance finalizes the revised draft guidance of the same
title issued on April 25, 2024 (89 FR 31757) (2024 draft guidance). FDA
considered comments received on the 2024 draft guidance as the guidance
was finalized.
Changes from the 2024 draft guidance to the final guidance include:
<bullet> Clarification that the recommendations in the guidance
apply regardless of the medium of communication (e.g., paper, digital)
<bullet> Further discussion related to the considerations that
firms should take into account when comparing biosimilar products and
reference products
<bullet> Editorial changes for consistency, readability, and
clarity
In conjunction with the enactment of the Biosimilar User Fee
Amendments of 2022 (BsUFA III), FDA agreed to work toward publishing a
final guidance on promotional labeling and advertising considerations
for interchangeable biosimilar products within 18 months after the
close of the public comment period on the draft guidance, as described
in the document titled ``Biosimilar Biological Product Reauthorization
Performance Goals and Procedures Fiscal Years 2023 through 2027.''
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 ``Promotional Labeling and Advertising
Considerations for Prescription Biological Reference Products,
Biosimilar Products, and Interchangeable Biosimilar Products: Questions
and Answers.'' 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.
FDA considered the applicability of Executive Order 14192, per OMB
guidance in M-25-20, and finds this action to be deregulatory in
nature.
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
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 314, Form FDA 2253 (Transmittal of Advertisements and
Promotional Labeling for Drugs and Biologics for Human Use), and the
guidance for industry entitled ``Providing Regulatory Submissions in
Electronic and Non-Electronic Format: Promotional Labeling and
Advertising Materials for Human Prescription Drugs'' have been approved
under OMB control number 0910-0001. The collections of information in
21 CFR 601.12 have been approved under OMB control number 0910-0338.
The collections of information in 21 CFR 202.1 and in the guidance for
industry entitled ``Medical Product Communications That Are Consistent
With the Food and Drug Administration Required Labeling: Questions and
Answers'' have been approved under OMB control number 0910-0686. The
collections of information in 21 CFR part 11 relating to electronic
records and signatures have been approved under OMB control number
0910-0303. The collections of information relating to the submission of
biosimilar and interchangeable product applications under section
351(k) of the Public Health Service Act (42 U.S.C. 262(k)) have been
approved under OMB control number 0910-0718.
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>.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22427 Filed 12-9-25; 8:45 am]
BILLING CODE 4164-01-P
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