[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Notices]
[Pages 74345-74346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0611]


Biosimilarity and Interchangeability: Additional Draft Q&As on 
Biosimilar Development and the Biologics Price Competition and 
Innovation Act of 2009; Draft Guidance for Industry; Availability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 or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Biosimilarity and Interchangeability: Additional Draft Q&As 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, as well as to describe FDA's 
interpretation of certain statutory requirements added by the Biologics 
Price Competition and Innovation Act of 2009 (BPCI Act). This draft 
guidance document provides new Q&As. It does not replace the draft 
guidance document entitled ``New and Revised Draft Q&As on Biosimilar 
Development and the BPCI Act (Revision 2),'' issued December 12, 2018.

DATES: Submit either electronic or written comments on the draft 
guidance by January 19, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 ``Biosimilarity and Interchangeability: Additional 
Draft Q&As 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 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 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 draft guidance document.

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 draft guidance for industry 
entitled ``Biosimilarity and Interchangeability:

[[Page 74346]]

Additional Draft Q&As 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, as well as to 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 has been using the format of Q&A guidance to describe the 
Agency's thinking on and update certain information and recommendations 
relevant to the development of biosimilar and interchangeable products. 
This draft guidance document contains only Q&As that are in draft form. 
After FDA has considered any comments on the Q&As contained in this 
draft guidance received during the relevant comment period and, as 
appropriate, incorporated suggested changes to the Q&A, individual Q&As 
will be finalized and moved to the final guidance document ``Questions 
and Answers on Biosimilar Development and the BPCI Act,'' which is 
updated as appropriate. The final guidance contains Q&As that have been 
through the public comment process and reflects FDA's current thinking 
on the topics described. 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 another FDA guidance document. No such changes to 
currently issued draft or final guidance documents are being made in 
connection with the issuance of this draft guidance.
    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'' and the December 2018 draft guidance 
``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act 
(Revision 2).'' This draft guidance document provides new Q&As. It does 
not replace the draft guidance document entitled ``New and Revised 
Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),'' 
issued December 12, 2018.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The Q&As in this draft 
guidance, when finalized, will appear in the final guidance, and the 
final guidance will represent the current thinking of FDA on the Q&As 
posed in the ``Biosimilarity and Interchangeability: Additional Draft 
Q&As 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

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). 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 
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 draft guidance 
at either 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.

    Dated: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25606 Filed 11-19-20; 8:45 am]
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