[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]


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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:
     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, 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
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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 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


