Notice2024-16128
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability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
July 23, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This draft guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act).
Full Text
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<title>Federal Register, Volume 89 Issue 141 (Tuesday, July 23, 2024)</title>
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[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Notices]
[Pages 59740-59742]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16128]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-2581]
Postapproval Manufacturing Changes to Biosimilar and
Interchangeable Biosimilar Products: Questions and Answers; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled
``Postapproval Manufacturing Changes to Biosimilar and Interchangeable
Biosimilar Products: Questions and Answers.'' This draft guidance
provides answers to commonly asked questions from applicants and other
interested parties regarding postapproval manufacturing changes made to
biosimilar and interchangeable biosimilar products licensed under the
Public Health Service Act (PHS Act).
DATES: Submit either electronic or written comments on the draft
guidance by September 23, 2024 to ensure that the Agency considers your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:
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<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-2024-D-2581 for ``Postapproval Manufacturing Changes to Biosimilar
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 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 to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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 the office in processing
your requests. The draft guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Nidhi Pamidimukkala, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002, 301-
796-3397, <a href="/cdn-cgi/l/email-protection#8fc1e6ebe7e6a1dfeee2e6ebe6e2fae4e4eee3eecfe9ebeea1e7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="85cbece1edecabd5e4e8ece1ece8f0eeeee4e9e4c5e3e1e4abededf6abe2eaf3">[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, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Postapproval Manufacturing Changes to Biosimilar and
Interchangeable Biosimilar Products: Questions and Answers.'' This
draft guidance provides answers to commonly asked questions from
applicants and other interested parties regarding postapproval
manufacturing changes (referred to as manufacturing changes throughout
this notice) made to biosimilar and interchangeable biosimilar products
licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k)). FDA is
publishing this draft guidance to fulfill the commitment made in the
2022 reauthorization of the Biosimilar User Fee Act (BsUFA III, Title
IV--Fees Relating to Biosimilar Biological Products, Pub. L. 112-144)
for fiscal years 2023 through 2027. This draft guidance is intended to
inform applicants on the nature and type of information, for different
reporting categories, that applicants should provide to support
manufacturing changes to licensed biosimilars and licensed
interchangeable biosimilars.
In the Federal Register of September 20, 2021 (86 FR 52154), FDA
published the notice of availability of a guidance for industry
entitled ``Questions and Answers on Biosimilar Development and the BPCI
Act,'' available at <a href="https://www.fda.gov/media/119258/download">https://www.fda.gov/media/119258/download</a> (Q&A
biosimilar development guidance) to provide answers to commonly asked
questions from applicants and other interested parties regarding the
licensure of biosimilars under the Biologics Price Competition and
Innovation Act of 2009. Postapproval manufacturing changes to
biosimilars was the subject of Q&A I.20 in the Q&A biosimilar
development guidance. FDA did not provide recommendations for
interchangeable biosimilar products because FDA had limited knowledge
and experience regarding manufacturing changes for licensed
interchangeable biosimilar products when that guidance issued. FDA has
since determined that the principles that apply to manufacturing
changes for biosimilars are relevant to interchangeable biosimilar
products. Thus, this draft guidance applies to manufacturing changes
made to both licensed biosimilar and licensed interchangeable
biosimilar products.
FDA may withdraw a Q&A that was previously in a guidance if FDA
determines that the issue described in the Q&A is addressed in another
guidance. Therefore, FDA intends to withdraw Q&A I.20 from the Q&A
biosimilar development guidance when this draft guidance becomes final.
FDA intends for this draft guidance to serve as a stand-alone guidance
from the Q&A biosimilar development guidance and will not retain the
same numbering of that guidance.
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 ``Postapproval
Manufacturing Changes to Biosimilar 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
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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 21 CFR 201.56 and 201.57 pertaining to
prescription product labeling requirements have been approved under OMB
control number 0910-0572; the collections of information in 21 CFR
parts 210 and 211 pertaining to current good manufacturing practice
have been approved under OMB control number 0910-0139; the collections
of information in section 351(k) of the PHS Act pertaining to
biosimilar and interchangeable biosimilar product applications have
been approved under OMB control number 0910-0718; and the collections
of information in section 351 of the PHS Act and 21 CFR part 601 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: July 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16128 Filed 7-22-24; 8:45 am]
BILLING CODE 4164-01-P
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