[Federal Register Volume 91, Number 46 (Tuesday, March 10, 2026)]
[Notices]
[Pages 11555-11556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-04664]
[[Page 11555]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0611]
New and Revised Draft Q&As on Biosimilar Development and the
Biologics Price Competition and Innovation Act; Draft Guidance for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, Agency, or we) is
announcing the availability of a revised draft guidance for industry
entitled ``New and Revised Draft Q&As on Biosimilar Development and the
BPCI Act (Revision 4).'' The question and answer (Q&A) format is
intended to inform prospective applicants and facilitate the
development of proposed biosimilar products and proposed
interchangeable biosimilar products, as well as describe FDA's proposed
interpretation of certain statutory requirements related to the
abbreviated licensure pathway for biological products added by the
Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This
draft guidance revises and replaces the draft guidance for industry
entitled ``New and Revised Draft Q&As on Biosimilar Development and the
BPCI Act (Revision 3)'' issued September 17, 2021 to provide certain
revisions to Q&As I.8, I.10, and I.19, which have been withdrawn from
the final guidance entitled ``Questions and Answers on Biosimilar
Development and the BPCI Act'' issued September 20, 2021.
DATES: Submit either electronic or written comments on the draft
guidance by May 11, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
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-2011-D-0611 for ``New and Revised Draft Q&As on Biosimilar
Development and the BPCI Act (Revision 4).'' 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. The draft
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or 240-402-8010 or emailing [email protected]. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Mustafa Unlu, Center for Drug
Evaluation and Research (HF-22), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 1139, Silver Spring, MD 20993-0001,
301-796-3396, [email protected]; or Philip
Kurs, Center for Biologics Evaluation and Research, Food and Drug
Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``New and Revised Draft Q&As on Biosimilar Development and the
BPCI Act (Revision 4).'' The BPCI Act amended the Public Health Service
Act (PHS Act) and other statutes to create an abbreviated licensure
pathway in section 351(k) of the PHS Act (42 U.S.C. 262(k)) for
biological products shown to be biosimilar to, or interchangeable with,
an FDA-licensed biological reference product (see sections 7001 through
7003 of the Patient Protection and Affordable Care Act (Pub. L. 111-
148)). FDA's view is that guidance for industry that provides answers
to commonly asked questions regarding FDA's interpretation of the BPCI
Act will enhance transparency and facilitate the development and
approval of biosimilar and interchangeable products.
This draft guidance is a companion to the final guidance for
industry issued in September 2021 entitled ``Questions and Answers on
Biosimilar Development and the BPCI Act.'' In this pair of guidance
documents, FDA issues each Q&A in draft form in a draft guidance,
receives comments on the draft Q&A and, as appropriate, moves the Q&A
to the final guidance after reviewing comments and incorporating
suggested changes to the Q&A. A Q&A that was previously in the final
guidance may be withdrawn and moved to a draft guidance if FDA
determines that the Q&A should be revised in some respect and reissued
in a revised draft Q&A for comment. Furthermore, a Q&A also may be
withdrawn and removed from a Q&A guidance if, for instance, the
concept(s) addressed by the Q&A is addressed, or would be addressed
more appropriately, in a different FDA guidance document.
This draft guidance contains Q&As distributed for comment purposes
only and includes proposed revisions to Q&As that appeared in previous
versions of the final guidance documents. The final guidance contains
Q&As that have been through the public comment process and reflects
FDA's current thinking on the topics described. While these guidances
have been revised over time, FDA has maintained the original numbering
of the Q&As as they were published in the original versions of these
guidances and subsequent revisions (available at https://www.regulations.gov/docket/FDA-2011-D-0611/document).
This draft guidance contains revised versions of three Q&As (Q&A
I.8, Q&A I.10, and Q&A I.19). The revised Q&A I.8 is now organized into
two parts: Part ``a'' describes FDA's updated recommendations regarding
how a clinical study (such as an assessment of pharmacokinetics (PK))
comparing the proposed biosimilar with a non-U.S.-licensed comparator
product could address, in part, the requirements under section
351(k)(2)(A) of the PHS Act and support a demonstration of
biosimilarity to the U.S.-licensed reference product in certain
circumstances. Part ``a'' also identifies circumstances under which
clinical data derived from a study using a non-U.S.-licensed comparator
product may be acceptable. Part ``b'' elaborates on recommendations
regarding the nature and extent of comparative analytical data between
the non-U.S.-licensed comparator product and the U.S.-licensed
reference product for purposes of the comparative analytical
assessment. FDA is specifically requesting public comment on the
utility of an analytical comparison between the proposed biosimilar
product and the non-U.S.-licensed comparator product as part of the
scientific justification to support the relevance of clinical data with
a non-U.S.-licensed comparator product to a demonstration of
biosimilarity to the U.S.-licensed reference product.
Additionally, minor updates were made to Q&As I.10 and Q&A I.19 for
clarity and to align with revised Q&A I.8. FDA's intent is that Part
``a'' of Q&A I.8 may inform a future revised guidance for industry
entitled ``Scientific Considerations in Demonstrating Biosimilarity to
a Reference Product'' and Part ``b'' may inform future revisions to a
guidance for industry entitled ``Development of Therapeutic Protein
Biosimilars: Comparative Analytical Assessment and Other Quality-
Related Considerations'' as appropriate.
At this time, FDA is also withdrawing Q&As I.8, I.10, and I.19 from
the final guidance entitled ``Questions and Answers on Biosimilar
Development and the BPCI Act'' issued September 20, 2021, and reissuing
the final guidance (with certain updates to the introductory text)
solely for the purpose of withdrawing these particular Q&As. The Agency
continues to evaluate other Q&As in this final guidance as part of its
efforts to further enhance efficiency in biosimilar development
programs and intends to update any Q&As that may no longer reflect the
Agency's current thinking, as appropriate.
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 ``New and
Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision
4).'' 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.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
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 relating to submission of an investigational new
drug application have been approved under OMB control number 0910-0014.
The collections of information relating to the submission of a BLA
under section 351(k) of the PHS Act, including the submission of data
from comparative analytical assessments and a clinical study or studies
(including the assessment of immunogenicity and PK or
pharmacodynamics), that are sufficient to demonstrate safety, purity,
and potency in one or more appropriate conditions of use for which the
reference product is licensed, as well as formal meetings between FDA
and sponsors, have been approved under OMB control number 0910-0718.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-04664 Filed 3-9-26; 8:45 am]
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