Notice2025-13682
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Guidance for Industry; Availability
Primary source
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Published
July 21, 2025
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 final guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products." This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of proposed biosimilar, including interchangeable biosimilar, products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title issued on August 11, 2023.
Full Text
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<title>Federal Register, Volume 90 Issue 137 (Monday, July 21, 2025)</title>
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[Federal Register Volume 90, Number 137 (Monday, July 21, 2025)]
[Notices]
[Pages 34278-34279]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13682]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1922]
Formal Meetings Between the Food and Drug Administration and
Sponsors or Applicants of Biosimilar User Fee Act Products; 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 final guidance for industry entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of BsUFA
Products.'' This guidance provides recommendations to industry on
formal meetings between FDA and sponsors or applicants relating to the
development and review of proposed biosimilar, including
interchangeable biosimilar, products regulated by the Center for Drug
Evaluation and Research (CDER) or the Center for Biologics Evaluation
and Research (CBER). This guidance finalizes the draft guidance of the
same title issued on August 11, 2023.
DATES: The announcement of the guidance is published in the Federal
Register on July 21, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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:
<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-2018-D-1922 for ``Formal Meetings Between the Food and Drug
Administration and Sponsors or Applicants of Biosimilar User Fee Act
Products.'' 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 this guidance to the
Division of Drug Information, Center for Drug
[[Page 34279]]
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Mustafa [Uuml]nl[uuml], 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 Phillip Kurs, Center for Biologics Evaluation and Research,
Food and Drug Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of BsUFA Products.'' This guidance provides recommendations to industry
on formal meetings between FDA and sponsors or applicants relating to
the development and review of proposed biosimilar, including
interchangeable biosimilar, products regulated by CDER or CBER. This
guidance does not apply to meetings associated with the development of
products intended for submission in, or review of, new drug
applications or abbreviated new drug applications under section 505 of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355),
biologics license applications under section 351(a) of the Public
Health Service Act (PHS Act) (42 U.S.C. 262(a)), or submissions for
devices under the FD&C Act. For the purposes of this guidance, a formal
meeting includes any meeting that is requested by a sponsor or
applicant following the procedures provided in this guidance and
includes meetings conducted in any format (i.e., in-person, virtual
(video conference), teleconference, or written response only). This
guidance discusses the principles of good meeting management practices
and describes standardized procedures for requesting, preparing,
scheduling, conducting, and documenting such formal meetings.
This guidance finalizes the draft guidance entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of BsUFA Products''
issued on August 11, 2023 (88 FR 54622). FDA considered comments
received on the draft guidance as the guidance was finalized. Changes
from the draft to the final guidance include clarification that
requesting a Biosimilar Initial Advisory meeting is not a requirement
prior to joining the Biosimilar Biological Product Development program,
additional description of in-person meetings and core attendees, and a
description regarding the maximum number of questions that should be
submitted within a single meeting request. In addition, editorial
changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Formal Meetings Between the FDA and
Sponsors or Applicants of BsUFA Products.'' 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 21 CFR part 312 related to the submission of an investigational new
drug application have been approved under OMB control number 0910-0014.
The collections of information in section 351(k) of the PHS Act and 21
CFR part 601 relating to the submission of biosimilar applications and
biosimilar user fee applications have been approved under OMB control
number 0910-0718.
III. Electronic Access
Persons with access to the internet may obtain the 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, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-13682 Filed 7-18-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on July 21, 2025.
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