Document ID: FDA-2019-D-5270-0001
Agency: fda
Document Type: Notice
Title: Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than
All Conditions of Use for Which the Reference Product Has Been Licensed; Draft Guidance for Industry; Availability
Posted Date: 2020-02-07T05:00Z

[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Notices]
[Pages 7313-7315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02421]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5270]

Biosimilars and Interchangeable Biosimilars: Licensure for Fewer 
Than All Conditions of Use for Which the Reference Product Has Been 
Licensed; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than 
All Conditions of Use for Which the Reference Product Has Been 
Licensed.'' When finalized, this draft guidance will provide 
recommendations to applicants seeking licensure under the Public Health 
Service Act (the PHS Act) of a proposed biosimilar or proposed 
interchangeable biosimilar for fewer than all of the reference 
product's licensed conditions of use. Additionally, when finalized, 
this draft guidance will also provide recommendations on the submission 
of a supplement to a licensed biologics license application (BLA) 
seeking to add a condition of use that previously has been licensed for 
the reference product to the labeling of a licensed biosimilar or 
interchangeable product, including considerations related to the timing 
of such submissions.

DATES: Submit either electronic or written comments on the draft 
guidance by April 7, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 7314]]

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 Docket No. FDA-
2019-D-5270 for ``Biosimilars and Interchangeable Biosimilars: 
Licensure for Fewer Than All Conditions of Use for Which the Reference 
Product Has Been Licensed.'' 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.
     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.
    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; or to 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 20993-0002, 301-
796-1042; 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Biosimilars and Interchangeable Biosimilars: Licensure for 
Fewer Than All Conditions of Use for Which the Reference Product Has 
Been Licensed.'' When finalized, this draft guidance will provide 
recommendations to applicants seeking licensure under section 351(k) of 
the PHS Act (42 U.S.C. 262(k)) of a proposed biosimilar or proposed 
interchangeable biosimilar for fewer than all of the reference 
product's licensed conditions of use. Additionally, when finalized, 
this draft guidance will also provide recommendations on the submission 
of a supplement to a licensed 351(k) BLA seeking to add a condition of 
use that previously has been licensed for the reference product to the 
labeling of a licensed biosimilar or interchangeable product, including 
considerations related to the timing of such submissions.
    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 ``Biosimilars 
and Interchangeable Biosimilars: Licensure for Fewer Than All 
Conditions of Use for Which the Reference Product Has Been Licensed.'' 
It does not establish any rights for any person and is not binding on 
FDA or the public. An alternative approach can be used if it satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521). 
The collections of information in 21 CFR part 312 have been approved 
under OMB control number 0910-0014. The collections of information in 
21 CFR part 601 have been approved under OMB control number 0910-0338. 
The collections of information for BLAs submitted under section 351(k) 
of the PHS Act have been approved under OMB control number 0910-0719. 
The collections of information in 21 CFR 201.56 and 21 CFR 201.57 have 
been

[[Page 7315]]

approved under OMB control number 0910-0572.

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, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: February 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02421 Filed 2-6-20; 8:45 am]
 BILLING CODE 4164-01-P