Notice2024-16405
Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments
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 25, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to obtain information and comments that will assist the Agency in assessing how best to advance the development of new biosimilar biological products (biosimilars or biosimilar products), as part of the Biosimilar User Fee Amendments of 2022 (BsUFA III). As FDA continues to advance the development of biosimilars, we are seeking input from industry on whether biosimilar product development would be best served by focusing on product class-specific guidance documents that address common development issues that apply to a broad class of products, or by developing product-specific guidance documents, similar to the approach taken in the Generic Drug User Fee Amendments (GDUFA) program.
Full Text
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<title>Federal Register, Volume 89 Issue 143 (Thursday, July 25, 2024)</title>
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[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60438-60439]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16405]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3228]
Biosimilar Product Development Guidance; Establishment of a
Public Docket; Request for Information and Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for
information and comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the establishment of a docket to obtain information and comments that
will assist the Agency in assessing how best to advance the development
of new biosimilar biological products (biosimilars or biosimilar
products), as part of the Biosimilar User Fee Amendments of 2022 (BsUFA
III). As FDA continues to advance the development of biosimilars, we
are seeking input from industry on whether biosimilar product
development would be best served by focusing on product class-specific
guidance documents that address common development issues that apply to
a broad class of products, or by developing product-specific guidance
documents, similar to the approach taken in the Generic Drug User Fee
Amendments (GDUFA) program.
DATES: Submit either electronic or written comments, data, or
information by October 23, 2024.
ADDRESSES: You may submit data, information, and comments as follows.
Please note that late, untimely filed comments will not be considered.
The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of October 23, 2024.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.
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-2024-N-3228 ``Biosimilar Product Development Guidance;
Establishment of a Public Docket; Request for Information and
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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
[[Page 60439]]
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.
FOR FURTHER INFORMATION CONTACT: Tiana Barnes, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6196, Silver Spring, MD 20993-0002, 301-
796-2882, <a href="/cdn-cgi/l/email-protection#712518101f105f3310031f1402311715105f1919025f161e07"><span class="__cf_email__" data-cfemail="24704d454a450a6645564a4157644240450a4c4c570a434b52">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The Biosimilar User Fee Act reauthorization, known as BsUFA III,\1\
authorizes FDA to assess and collect user fees for certain activities
in connection with biosimilar product development and review of
applications submitted under section 351(k) of the Public Health
Service Act (PHS Act) (42 U.S.C. 262(k)). An application submitted
under section 351(k) of the PHS Act must demonstrate, among other
things, that a proposed biosimilar product is highly similar to, and
has no clinically meaningful differences from, an FDA-licensed
reference product. To date, FDA has issued a series of guidance
documents to facilitate development of biosimilar products. Under
section 351(k)(8)(D) of the PHS Act, if FDA issues product class-
specific guidance with respect to the licensure of biosimilar products,
the guidance must include a description of the criteria that FDA will
use to determine whether a biological product is highly similar to a
reference product in such product class and the criteria, if available,
that FDA will use to determine whether a biological product meets the
standards for interchangeability described in section 351(k)(4) of the
PHS Act.
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\1\ See <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027</a>.
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Under BsUFA III, FDA has committed to, among other things, the
development of guidance documents focusing on formal meetings between
FDA and sponsors or applicants of BsUFA products and topics related to
interchangeable biosimilar biological products (interchangeable
biosimilars or interchangeable biosimilar products) (see Biosimilar
Biological Product Reauthorization Performance Goals and Procedures
Fiscal Years 2023 Through 2027, available at <a href="https://www.fda.gov/media/152279/download">https://www.fda.gov/media/152279/download</a>). These guidance documents are not product-specific or
product class-specific but rather apply across many products and
product classes. In contrast, under the GDUFA science and research
program, FDA conducts research in support of various regulatory science
initiatives, the results of which support development of both general
and product-specific guidance for industry.
As part of the BsUFA III program, FDA has updated its biosimilar
action plan \2\ and is revisiting how best to advance the development
of new biosimilar products. FDA guidance can enhance scientific and
regulatory clarity for the biosimilar product development community
and, when finalized, represents FDA's current thinking on the matter.
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\2\ See <a href="https://www.fda.gov/drugs/biosimilars/biosimilars-action-plan#clarity">https://www.fda.gov/drugs/biosimilars/biosimilars-action-plan#clarity</a>.
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II. Issues for Consideration and Request for Information and Comments
FDA is seeking input from industry on whether product-specific
guidance outlining the development program for a particular product
would be valuable to the biosimilar product development community. A
model for this approach is the GDUFA science and research program that,
among other things, supports the issuance of product-specific guidance
documents, of which there are currently over 2,000.\3\ Alternatively,
FDA is seeking input on whether product class-specific guidance, which
may apply more broadly to a class of products, would be valuable to the
biosimilar product development community. Specifically, FDA is seeking
input on the following questions:
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\3\ See the Product-Specific Guidances for Generic Drug
Development web page at <a href="https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm">https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm</a>.
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1. Which would be more useful for accelerating biosimilar
development: guidance documents that focus on a particular product
(product-specific guidance), or guidance documents that are cross-
cutting for a class of biosimilar products (product class-specific
guidance) such as monoclonal antibodies?
2. Should FDA focus on development of guidance documents for
biological products (or classes of biological products) for which there
are no approved biosimilars? Or would it be useful for FDA to continue
to develop guidance on biosimilar development programs even after one
or more biosimilar products have been approved for that biological
product or class of biological products?
Dated: July 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16405 Filed 7-24-24; 8:45 am]
BILLING CODE 4164-01-P
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