[Federal Register Volume 89, Number 81 (Thursday, April 25, 2024)]
[Notices]
[Pages 31757-31759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08886]


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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; Revised 
Draft Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled 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revised draft guidance to address questions that manufacturers, 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FDA agreed to publish a draft guidance on promotional labeling and 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 The revised draft guidance is consistent with this 
commitment and replaces the draft guidance for industry entitled 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DATES: Submit either electronic or written comments on the draft 
guidance by June 24, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, [email protected]; 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:
     Identifying reference products and biosimilar products
     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
     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))
     Presenting comparisons between a reference product and its 
biosimilar product(s)
     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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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