[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52060-52062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Reference Product: Update; Draft Guidance for Industry; Availability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announcing the availability of a draft guidance for industry entitled 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 This draft guidance describes considerations 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for this draft guidance, we intend to revise the final guidance for 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that document regarding the subject addressed in this draft guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by August 20, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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

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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 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-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 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 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: 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 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: 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