[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Notices]
[Pages 59740-59742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16128]


-----------------------------------------------------------------------

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Interchangeable Biosimilar Products: Questions and Answers; Draft 
Guidance for Industry; Availability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.

-----------------------------------------------------------------------

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the availability of a draft guidance for industry entitled 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 This draft guidance 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DATES: Submit either electronic or written comments on the draft 
guidance by September 23, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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:

[[Page 59741]]

     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-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 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 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, [email protected]; 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 https://www.fda.gov/media/119258/download (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

[[Page 59742]]

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 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: 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