[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65822-65823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25919]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5255]


Clinical Immunogenicity Considerations for Biosimilar and 
Interchangeable Insulin Products; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Clinical 
Immunogenicity Considerations for Biosimilar and Interchangeable 
Insulin Products.'' The purpose of this draft guidance is to provide 
recommendations to applicants regarding whether and when comparative 
clinical immunogenicity studies may be needed to support licensure of 
proposed biosimilar and interchangeable recombinant human insulins, 
recombinant human insulin mix products, and recombinant insulin analog 
products that are intended for the treatment of patients with Type 1 or 
Type 2 diabetes mellitus.

DATES: Submit either electronic or written comments on the draft 
guidance by January 28, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

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-2019-D-5255 for ``Clinical Immunogenicity Considerations for 
Biosimilar and Interchangeable Insulin Products.'' 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

[[Page 65823]]

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.gpo.gov/fdsys/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. 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; sandra.benton@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Clinical Immunogenicity Considerations for Biosimilar and 
Interchangeable Insulin Products.'' The purpose of this draft guidance 
is to provide recommendations to applicants regarding whether and when 
comparative clinical immunogenicity studies may be needed to support 
licensure of proposed biosimilar and interchangeable recombinant human 
insulins, recombinant human insulin mix products, and recombinant 
insulin analog products that are intended for the treatment of patients 
with Type 1 or Type 2 diabetes mellitus (collectively referred to as 
``insulin products'').
    Section 7002(e)(4) of the Biologics Price Competition and 
Innovation Act of 2009 (BPCI Act) requires that on March 23, 2020, an 
approved application for a biological product under section 505 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) will be 
deemed to be a license for the biological product under section 351 of 
the Public Health Service Act (PHS Act) (42 U.S.C. 262). Although the 
majority of therapeutic biological products have been licensed under 
section 351 of the PHS Act, some protein products historically have 
been approved under section 505 of the FD&C Act. The BPCI Act clarified 
the statutory authority under which certain protein products will be 
regulated by amending the definition of a ``biological product'' in 
section 351(i) of the PHS Act to include a ``protein (except any 
chemically synthesized polypeptide),'' and describing procedures for 
submission of a marketing application for certain ``biological 
products.''
    The biological products affected by this transition include insulin 
products. On March 23, 2020, the approved new drug applications (NDAs) 
for insulin products will be deemed to be licenses under section 351(a) 
of the PHS Act. Such deemed BLAs will then be available to be used as 
reference products by applicants seeking licensure of proposed 
biosimilar and interchangeable insulin products under section 351(k) of 
the PHS Act.
    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 ``Clinical 
Immunogenicity Considerations for Biosimilar and Interchangeable 
Insulin Products.'' 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 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 submission of an investigational new drug application is covered 
under 21 CFR part 312 and approved under OMB control number 0910-0014. 
The submission of a BLA under section 351(a) of the PHS Act is covered 
under 21 CFR part 601 and approved under OMB control number 0910-0338. 
The submission of a BLA under section 351(k) of the PHS Act is covered 
under 21 CFR part 601 and 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 or 
https://www.regulations.gov.

    Dated: November 21, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-25919 Filed 11-27-19; 8:45 am]
BILLING CODE 4164-01-P


