[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60438-60439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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 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-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 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

[[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, [email protected].

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 https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027.
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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 https://www.fda.gov/media/152279/download). 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 https://www.fda.gov/drugs/biosimilars/biosimilars-action-plan#clarity.
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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 https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm.
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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