Notice2024-13429
Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry; Availability
Primary source
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Published
June 21, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Considerations in Demonstrating Interchangeability With a Reference Product: Update." This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). After considering any comments received in the docket for this draft guidance, we intend to revise the final guidance for industry entitled "Considerations in Demonstrating Interchangeability With a Reference Product" issued on May 14, 2019, to amend sections in that document regarding the subject addressed in this draft guidance.
Full Text
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<title>Federal Register, Volume 89 Issue 120 (Friday, June 21, 2024)</title>
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[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52060-52062]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13429]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-0154]
Considerations in Demonstrating Interchangeability With a
Reference Product: Update; Draft Guidance for Industry; Availability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, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Considerations in Demonstrating Interchangeability With a Reference
Product: Update.'' This draft guidance describes considerations
regarding a switching study or studies intended to support a
demonstration that a proposed therapeutic protein product is
interchangeable with a reference product for the purposes of submitting
a marketing application or supplement under the Public Health Service
Act (PHS Act). After considering any comments received in the docket
for this draft guidance, we intend to revise the final guidance for
industry entitled ``Considerations in Demonstrating Interchangeability
With a Reference Product'' issued on May 14, 2019, to amend sections in
that document regarding the subject addressed in this draft guidance.
DATES: Submit either electronic or written comments on the draft
guidance by August 20, 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
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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-2017-D-0154 for ``Considerations in Demonstrating
Interchangeability With a Reference Product: Update.'' 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 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: Mustafa Unlu, 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 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 draft guidance for industry
entitled ``Considerations in Demonstrating Interchangeability With a
Reference Product: Update.'' This draft guidance describes
considerations regarding a switching study or studies intended to
support a demonstration that a proposed therapeutic protein product is
interchangeable with a reference product for the purposes of submitting
a marketing application or supplement under section 351(k) of the PHS
Act (42 U.S.C. 262(k)). After considering any comments received in the
docket for this draft guidance, we intend to revise the final guidance
for industry entitled ``Considerations in Demonstrating
Interchangeability With a Reference Product'' (Interchangeability
Guidance) issued on May 14, 2019 (84 FR 21342) to amend sections in
that document regarding the subject addressed in this draft guidance.
FDA issued the Interchangeability Guidance before receiving and
reviewing any biologics license applications submitted under section
351(k) of the PHS Act for a proposed interchangeable biosimilar
product. Since publication of the Interchangeability Guidance,
experience has shown that for the products approved as biosimilars to
date, the risk in terms of safety or diminished efficacy is
insignificant following single or multiple switches between a reference
product and a biosimilar product. Accordingly, FDA's scientific
approach to when a switching study or studies may be needed to support
a demonstration of interchangeability has evolved.
This draft guidance is not intended to be finalized as a standalone
guidance. Instead, the recommendations in this draft guidance, when
finalized, are intended to revise the Interchangeability Guidance and
to replace sections in that document, such as sections VI.A and VII, to
reflect FDA's current thinking regarding the subject addressed in this
guidance. FDA is issuing this draft guidance to seek public comment
through the accompanying docket.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). 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
for the submission of a biologics license application or supplemental
application under section 351(k) of the PHS Act have been approved
under OMB control number 0910-0718. The collections of information in
21 CFR part 312 for the
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submissions of investigational new drug applications have been approved
under OMB control number 0910-0014. The collections of information in
21 CFR part 314 for the submissions of new drug applications have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR part 601 for the submissions of biologics license
application and supplemental applications have been approved under OMB
control number 0910-0338.
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: June 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13429 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on June 21, 2024.
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