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Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Revised Draft Guidance for Industry; Availability, 31757-31759 [2024-08886]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
the effective date of re-approval. If we
determine that AABB has failed to
adopt, maintain, and enforce
requirements that are equal to, or more
stringent than, the CLIA requirements or
that systemic problems exist in its
monitoring, inspection, or enforcement
processes, we may impose a
probationary period, not to exceed 1
year, in which AABB would be allowed
to address any identified issues. Should
AABB be unable to address the
identified issues within that timeframe,
we may, in accordance with the
applicable regulations, revoke AABB’s
deeming authority under CLIA.
Should circumstances result in our
withdrawal of AABB’s re-approval, we
will publish a notice in the Federal
Register explaining the basis for
removing its re-approval.
VI. Collection of Information
Requirements
The information collection
requirements associated with the
accreditation process for clinical
laboratories under the CLIA program are
currently OMB-approved under OMB
control number 0938–0686 and expire
May 31, 2025. Additionally, this notice
does not impose any new or revised
information collection requirements,
that is, reporting, recordkeeping, or
third-party disclosure requirements.
Consequently, it does not need to be
reviewed by the Office of Management
and Budget (OMB) under the authority
of the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq).
VII. Executive Order 12866 Statement
lotter on DSK11XQN23PROD with NOTICES1
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Trenesha Fultz-Mimms, who
is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2024–08809 Filed 4–24–24; 8:45 am]
BILLING CODE P
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.
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.
SUMMARY:
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.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
VerDate Sep<11>2014
18:54 Apr 24, 2024
Jkt 262001
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
31757
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
E:\FR\FM\25APN1.SGM
25APN1
lotter on DSK11XQN23PROD with NOTICES1
31758
Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
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-201509-18/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,
VerDate Sep<11>2014
18:54 Apr 24, 2024
Jkt 262001
MD 20993–0002, 301–796–1200, CDEROPDP-RPM@fda.hhs.gov; 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 FDAregulated 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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 FDAapproved 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 FDAapproved 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’’
E:\FR\FM\25APN1.SGM
25APN1
31759
Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0477]
Agency Information Collection
Revision 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
SUMMARY:
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before June 24, 2024.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0477–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Incident Report
Form.
Type of Collection: Reinstatement
with Change.
OMB No.: 0990–0477.
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections (OHRP), is
requesting reinstatement of the OMB
No. 0990–0477, Incident Report Form,
with two new information elements on
the Incident Report form: IORG # for
Reviewing IRB; and, Revising research
policies and procedures as a corrective
action plan category, if it applies. The
purpose of the Incident Report form is
to facilitate organizations or institutions
prompt reporting of specific human
subject protection incidents to OHRP, in
a simplified standardized format, as
required by HHS protection of human
subjects regulations at 45 CFR part 46.
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
Forms name
Number of
responses per
respondents
Average
burden per
response
Total burden
hours
Incident Report ................................................................................................
Incident Report ................................................................................................
Incident Report ................................................................................................
25
25
200
1
3
5
30/60
30/60
30/60
12.5
37.5
500
Total ..........................................................................................................
........................
........................
........................
550
VerDate Sep<11>2014
18:54 Apr 24, 2024
Jkt 262001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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:
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
