Notice2021-20255
Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability
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Published
September 20, 2021
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 revised final guidance for industry entitled "Questions and Answers on Biosimilar Development and the BPCI Act." The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, and also describes FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled "Questions and Answers on Biosimilar Development and the BPCI Act" issued December 12, 2018.
Full Text
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<title>Federal Register, Volume 86 Issue 179 (Monday, September 20, 2021)</title>
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[Federal Register Volume 86, Number 179 (Monday, September 20, 2021)]
[Notices]
[Pages 52154-52156]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20255]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0611]
Questions and Answers on Biosimilar Development and the Biologics
Price Competition and Innovation Act of 2009; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised final guidance for industry entitled
``Questions and Answers on Biosimilar Development and the BPCI Act.''
The question and answer (Q&A) format is intended to inform prospective
applicants and facilitate the development of proposed biosimilars and
proposed interchangeable biosimilars, and also describes FDA's
interpretation of certain statutory requirements added by the Biologics
Price Competition and Innovation Act of 2009 (BPCI Act). This guidance
document revises the final guidance document entitled ``Questions and
Answers on Biosimilar Development and the BPCI Act'' issued December
12, 2018.
DATES: The announcement of the guidance is published in the Federal
Register on September 20, 2021.
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-2011-D-0611 for ``Questions and Answers on Biosimilar Development
and the BPCI Act.'' 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 Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, 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 that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
[[Page 52155]]
FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, 301-796-
1042, <a href="/cdn-cgi/l/email-protection#267547484254470864434852494866404247084e4e5508414950"><span class="__cf_email__" data-cfemail="bae9dbd4dec8db94f8dfd4ced5d4fadcdedb94d2d2c994ddd5cc">[email protected]</span></a> or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911, <a href="/cdn-cgi/l/email-protection#1f4c6b7a6f777a71314d766f737a665f797b7e3177776c31787069"><span class="__cf_email__" data-cfemail="5c0f28392c343932720e352c3039251c3a383d7234342f723b332a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised final guidance for
industry entitled ``Questions and Answers on Biosimilar Development and
the BPCI Act.'' The Q&A format is intended to inform prospective
applicants and facilitate the development of proposed biosimilars and
proposed interchangeable biosimilars, and also describe FDA's
interpretation of certain statutory requirements added by the BPCI Act.
The BPCI Act created 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
believes 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. FDA intends to update this
guidance to include additional Q&As as appropriate.
FDA issues biosimilar Q&A guidances that contain Q&As about
biosimilar and interchangeable products. This final guidance document
contains all Q&As that are in final form. The November 2020 draft
guidance entitled ``Biosimilarity and Interchangeability: Additional
Draft Q&As on Biosimilar Development and the BPCI Act'' (Additional
Draft Q&A Guidance) and the draft guidance entitled ``New and Revised
Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)''
(New and Revised Draft Q&A Guidance) contain draft Q&As. After FDA has
considered any comments on the Q&As contained in the draft guidances,
received during the relevant comment period and, as appropriate,
incorporated suggested changes to the Q&A, individual Q&As will be
moved to the final guidance document. This final guidance document
contains Q&As that have been through the public comment process and
reflects FDA's current thinking on the topics described.
This guidance document revises the final guidance document entitled
``Questions and Answers on Biosimilar Development and the BPCI Act'' to
clarify and update certain Q&As and add additional Q&As. For certain
Q&As, FDA updated the Q&A by referring the reader to a separate
guidance document that provides additional information on the topic. In
addition, a Q&A may be withdrawn and removed from the Q&A guidance
documents if, for instance, the issue addressed in the Q&A has been
addressed in a separate FDA guidance document.
FDA has maintained the original numbering of the Q&As used in the
December 2018 final guidance, ``Questions and Answers on Biosimilar
Development and the BPCI Act,'' the December 2018 draft guidance, ``New
and Revised Draft Q&As on Biosimilar Development and the BPCI Act
(Revision 2),'' and the Additional Draft Q&A Guidance.
Table 1--Status of Draft Guidance Q&As and Final Guidance Q&As
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Previous guidance Current guidance
Q&A category Q&A No. location location
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Part I. Biosimilarity or Q.I.1.................. Final.................. Final.
Interchangeability.
Q.I.2.................. Final.................. Final.
Q.I.3.................. Final.................. Final.
Q.I.4.................. Final.................. Final.
Q.I.5.................. Final.................. Final.
Q.I.6.................. Final.................. Final.
Q.I.7.................. Final.................. Final.
Q.I.8.................. Final.................. Final.
Q.I.9.................. Final.................. Final.
Q.I.10................. Final.................. Final.
Q.I.11................. Withdrawn.............. Withdrawn.
Q.I.12................. Draft.................. Draft.*
Q.I.13................. Final.................. Final.
Q.I.14................. Final.................. Final.
Q.I.15................. Final.................. Final.
Q.I.16................. Draft.................. Final.
Q.I.17................. Final.................. Final.
Q.I.18................. Final.................. Final.
Q.I.19................. Final.................. Final.
Q.I.20................. Draft.................. Final.
Q.I.21................. Draft.................. Final.
Q.I.22................. Draft.................. Final.
Q.I.23................. Draft.................. Withdrawn.
Q.I.24................. Draft.................. Final.
Q.I.25................. ....................... Draft.
Q.I.26................. ....................... Draft.
Q.I.27................. ....................... Draft.
Q.I.28................. ....................... Draft.
Part II. Provisions Related to Q.II.1................. Draft.................. Withdrawn.
Requirements to Submit a Biologics
License Application (BLA) for a
``Biological Product''.
Q.II.2................. Final.................. Final.
[[Page 52156]]
Q.II.3................. Final.................. Final.
Part III. Exclusivity................ Q.III.1................ Final.................. Final.
Q.III.2................ Final.................. Final.
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* The draft Q&A continues to be available in the New and Revised Draft Q&A Guidance (Revision 3). All other
draft Q&As are available in the Additional Draft Q&A Guidance.
This guidance finalizes all but three of the Q&As that were
included in the draft guidance ``New and Revised Draft Q&As on
Biosimilar Development and the BPCI Act (Revision 2)'' issued on
December 12, 2018. FDA considered comments it received regarding these
Q&As, and made changes to the Q&As, as appropriate; for example,
providing additional and clearer information in Q.I.16 and providing
additional information about text in the labeling for a biosimilar in
Q.I.22. FDA also made certain clarifying and editorial changes to
update previously finalized Q&As. Editorial changes were made primarily
for clarification.
FDA has retained Q.I.12 in draft and transferred it to ``New and
Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision
3).'' This draft Q&A addresses how an applicant can demonstrate that
its proposed injectable biosimilar product or proposed injectable
interchangeable product has the same ``strength'' as the reference
product. FDA withdrew Q.I.23, which addressed a process for obtaining
certain letters related to reference product access for testing for
products with risk evaluation and mitigation strategy with elements to
assure safe use. In light of the enactment of the Further Consolidated
Appropriations Act, 2020 (FCA Act) (Pub. L. 116-94), which includes
provisions related to this topic (see Division N, section 610, of the
FCA Act (21 U.S.C. 355-2)), FDA intends to issue guidance describing
how the existing process for obtaining these letters is being aligned
with the framework set forth in the new law. FDA also withdrew Q.II.1,
which addressed the definition of ``protein.'' For information on the
definition of ``protein'' in section 351(i)(1) of the PHS Act, see the
final rule entitled ``Definition of the Term `Biological Product' ''
(85 FR 10057, February 21, 2020; 21 CFR 600.3(h)(6)).
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 ``Questions and Answers on Biosimilar
Development and the BPCI Act.'' 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 for submission of an investigational
new drug application have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314.50 for
submission of a new drug application have been approved under OMB
control number 0910-0001. The collections of information in section
351(a) of the PHS Act and 21 CFR part 601 for submission of a biologics
license application (BLA) have been approved under OMB control number
0910-0338. The collections of information in section 351(k) of the PHS
Act and 21 CFR part 601 for submission of a BLA have been approved
under OMB control number 0910-0719.
III. Electronic Access
Persons with access to the internet may obtain the final guidance
at either <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>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: September 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20255 Filed 9-17-21; 8:45 am]
BILLING CODE 4164-01-P
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