Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability, 52154-52156 [2021-20255]
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Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices
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BILLING CODE 6714–01–P
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
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
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
SUMMARY:
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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:
• 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 ‘‘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
https://www.regulations.gov or at the
Dockets Management Staff between
9 a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
PO 00000
Frm 00032
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• 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-201509-18/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 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.
E:\FR\FM\20SEN1.SGM
20SEN1
Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices
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, Sandra.Benton@fda.hhs.gov 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, Stephen.Ripley@fda.hhs.gov.
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
Q&A category
Q&A No.
Previous guidance
location
Part I. Biosimilarity or Interchangeability.
Q.I.1 ..............................................
Final ..............................................
Final.
Q.I.2 ..............................................
Q.I.3 ..............................................
Q.I.4 ..............................................
Q.I.5 ..............................................
Q.I.6 ..............................................
Q.I.7 ..............................................
Q.I.8 ..............................................
Q.I.9 ..............................................
Q.I.10 ............................................
Q.I.11 ............................................
Q.I.12 ............................................
Q.I.13 ............................................
Q.I.14 ............................................
Q.I.15 ............................................
Q.I.16 ............................................
Q.I.17 ............................................
Q.I.18 ............................................
Q.I.19 ............................................
Q.I.20 ............................................
Q.I.21 ............................................
Q.I.22 ............................................
Q.I.23 ............................................
Q.I.24 ............................................
Q.I.25 ............................................
Q.I.26 ............................................
Q.I.27 ............................................
Q.I.28 ............................................
Q.II.1 .............................................
Final ..............................................
Final ..............................................
Final ..............................................
Final ..............................................
Final ..............................................
Final ..............................................
Final ..............................................
Final ..............................................
Final ..............................................
Withdrawn .....................................
Draft ..............................................
Final ..............................................
Final ..............................................
Final ..............................................
Draft ..............................................
Final ..............................................
Final ..............................................
Final ..............................................
Draft ..............................................
Draft ..............................................
Draft ..............................................
Draft ..............................................
Draft ..............................................
.......................................................
.......................................................
.......................................................
.......................................................
Draft ..............................................
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Withdrawn.
Draft.*
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Withdrawn.
Final.
Draft.
Draft.
Draft.
Draft.
Withdrawn.
Q.II.2 .............................................
Final ..............................................
Final.
Part II. Provisions Related to Requirements to Submit a Biologics
License Application (BLA) for a
‘‘Biological Product’’.
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Current guidance
location
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Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices
TABLE 1—STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS—Continued
Q&A category
Q&A No.
Previous guidance
location
Current guidance
location
Part III. Exclusivity .........................
Q.II.3 .............................................
Q.III.1 ............................................
Q.III.2 ............................................
Final ..............................................
Final ..............................................
Final ..............................................
Final.
Final.
Final.
* 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
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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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Paperwork Reduction Act of 1995
Meeting of the National Advisory
Council on Migrant Health
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
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: September 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–20255 Filed 9–17–21; 8:45 am]
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Health Resources and Services
Administration
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
National Advisory Council on Migrant
Health (NACMH or Council) has
scheduled a public meeting. Information
about NACMH and the agenda for this
meeting can be found on the NACMH
website at: https://bphc.hrsa.gov/
qualityimprovement/strategic
partnerships/nacmh.
DATES: November 2–5, 2021; 12:30
p.m.–4:30 p.m. Eastern Time each day.
ADDRESSES: This meeting will be held
by webinar. Instructions for joining the
meeting will be posted on the NACMH
website 30 business days before the
meeting date. For meeting information
updates, go to the NACMH website at:
https://bphc.hrsa.gov/quality
improvement/strategicpartnerships/
nacmh.
FOR FURTHER INFORMATION CONTACT:
Esther Paul, NACMH Designated
Federal Officer, Strategic Initiatives and
Planning Division, Office of Policy and
Program Development, Bureau of
Primary Health Care, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; 301–594–4300; or epaul@
hrsa.gov.
SUPPLEMENTARY INFORMATION: NACMH
is a non-discretionary advisory body
mandated by the Public Health Service
Act, Title 42 U.S.C. 218, to advise,
consult with, and make
recommendations to the Secretary of the
Department of Health and Human
Services and the Administrator of HRSA
regarding the organization, operation,
selection, and funding of migrant health
centers and other entities funded under
section 330(g) of the Public Health
SUMMARY:
E:\FR\FM\20SEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 179 (Monday, September 20, 2021)]
[Notices]
[Pages 52154-52156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20255]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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 ``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 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 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, [email protected] 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, [email protected].
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
----------------------------------------------------------------------------------------------------------------
Previous guidance Current guidance
Q&A category Q&A No. location location
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
* 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 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, or https://www.regulations.gov.
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
