Notice2024-08886
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Revised Draft Guidance for Industry; Availability
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
April 25, 2024
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers." FDA is issuing this revised draft guidance to address questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling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). In conjunction with the enactment of the Biosimilar User Fee Amendments of 2022 (BsUFA III), FDA agreed to publish a draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products, as described in the document titled "Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027." The revised draft guidance is consistent with this commitment and replaces the draft guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers" issued on February 4, 2020.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 81 (Thursday, April 25, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 81 (Thursday, April 25, 2024)]
[Notices]
[Pages 31757-31759]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-08886]
-----------------------------------------------------------------------
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; Revised
Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Promotional Labeling and Advertising Considerations for Prescription
Biological Reference Products, Biosimilar Products, and Interchangeable
Biosimilar Products: Questions and Answers.'' FDA is issuing this
revised draft guidance to address 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). In conjunction with the
enactment of the Biosimilar User Fee Amendments of 2022 (BsUFA III),
FDA agreed to publish a draft guidance on promotional labeling and
advertising considerations for interchangeable biosimilar products, as
described in the document titled ``Biosimilar Biological Product
Reauthorization Performance Goals and Procedures Fiscal Years 2023
through 2027.'' The revised draft guidance is consistent with this
commitment and replaces the draft guidance for industry entitled
``Promotional Labeling and Advertising Considerations for Prescription
Biological Reference and Biosimilar Products: Questions and Answers''
issued on February 4, 2020.
DATES: Submit either electronic or written comments on the draft
guidance by June 24, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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
[[Page 31758]]
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 the draft 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; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Alpita Popat, 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#1b585f5e4936544b5f4b36494b565b7d7f7a35737368357c746d"><span class="__cf_email__" data-cfemail="cf8c8b8a9de2809f8b9fe29d9f828fa9abaee1a7a7bce1a8a0b9">[email protected]</span></a>; or
James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Promotional Labeling and Advertising Considerations
for Prescription Biological Reference Products, Biosimilar Products,
and Interchangeable Biosimilar Products: Questions and Answers.'' The
revised draft 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. Reference product, as defined in section 351(i)(4) of the
PHS Act, means the single biological product licensed under section
351(a) of the PHS Act against which a biological product is evaluated
in an application submitted under section 351(k) of the PHS Act. This
guidance does not make any recommendations for nonprescription
products. Unless otherwise specified, the term biosimilar product as
used in this revised draft guidance refers to a product that is
licensed under section 351(k) of the PHS Act as biosimilar to or
biosimilar to and interchangeable with a reference product.
Section 351(k) of the PHS Act provides an abbreviated licensure
pathway for biological products shown to be biosimilar to or biosimilar
to and 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 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 (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 (351(i)(3) of the
PHS Act).
FDA is providing this revised draft guidance to address questions
firms may have when developing FDA-regulated promotional communications
for prescription reference products or prescription biosimilar
products, including interchangeable biosimilar products. The revised
draft guidance discusses considerations for presenting data and
information about reference products or biosimilar products in these
promotional communications to help ensure that they are accurate,
truthful and non-misleading. The revised draft 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 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 and the
biosimilar products
<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 (see the guidance for industry
entitled ``Medical Product Communications That Are Consistent With the
FDA-Required Labeling: Questions and Answers'' (June 2018))
<bullet> Presenting comparisons between a reference product and its
biosimilar product(s)
<bullet> Submitting promotional communications to FDA
The revised draft guidance also provides examples to illustrate
some of the considerations outlined in the guidance.
This revised draft guidance replaces the draft guidance for
industry ``Promotional Labeling and Advertising Considerations for
Prescription Biological Reference and Biosimilar Products: Questions
and Answers''
[[Page 31759]]
issued on February 4, 2020 (85 FR 6201) (2020 draft guidance). In
revising this guidance, FDA considered comments received on the 2020
draft guidance and expanded the scope of the 2020 draft guidance to
fulfill the BsUFA III commitment to publish draft guidance on
promotional labeling and advertising considerations for interchangeable
biosimilar products. Changes from the 2020 draft guidance include
additional recommendations and an example for interchangeable
biosimilar products. In addition, editorial changes were made to
improve clarity.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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.
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 FDA's guidance entitled ``Providing Regulatory Submissions in
Electronic and Non-Electronic Format: Promotional Labeling and
Advertising Materials for Human Prescription Drugs,'' the collections
of information in 21 CFR part 314, and the collections of information
resulting from submissions using Form FDA 2253 (Transmittal of
Advertisements and Promotional Labeling for Drugs and Biologics for
Human Use) 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 have been approved under OMB control number 0910-0686; the
collections of information in FDA's guidance 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 0910-0856; the collections of
information in 21 CFR part 11 pertaining to electronic records and
signatures have been approved under OMB control number 0910-0303; and
the collections of information relating to section 351(k) of the Public
Health Service Act relating to biosimilar and interchangeable product
applications have been approved under OMB control number 0910-0718.
III. Electronic Access
Persons with access to the internet may obtain the draft 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>.
Dated: April 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08886 Filed 4-24-24; 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 April 25, 2024.
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.