83 FR 34141 - Labeling for Biosimilar Products; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 139 (July 19, 2018)

Page Range		34141-34142
FR Document		2018-15391

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Labeling for Biosimilar Products.'' This guidance is intended to help applicants develop draft labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for certain recommendations pertaining to FDA- approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). This guidance provides an overview of FDA's recommendations for labeling for biosimilar products. This guidance finalizes the draft guidance issued on April 4, 2016.

Federal Register, Volume 83 Issue 139 (Thursday, July 19, 2018)

[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Pages 34141-34142]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-15391]

[[Page 34141]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0643]

Labeling for Biosimilar Products; 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 final guidance for industry entitled ``Labeling
for Biosimilar Products.'' This guidance is intended to help applicants
develop draft labeling for proposed biosimilar products. The
recommendations for prescription drug labeling in this guidance pertain
only to the prescribing information (commonly referred to as the
package insert), except for certain recommendations pertaining to FDA-
approved patient labeling (e.g., Patient Information, Medication Guide,
and Instructions for Use). This guidance provides an overview of FDA's
recommendations for labeling for biosimilar products. This guidance
finalizes the draft guidance issued on April 4, 2016.

DATES: The announcement of the guidance is published in the Federal
Register on July 19, 2018.

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-2016-D-0643 for ``Labeling for Biosimilar Products; Guidance for
Industry; Availability.'' 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.thefederalregister.org/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 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.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993, 301-796-
1042; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7268, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry
entitled ``Labeling for Biosimilar Products.'' The Biologics Price
Competition and Innovation Act of 2009 (BPCI Act), enacted as part of
the Patient Protection and Affordable Care Act (Affordable Care Act)
(Pub. L. 111-148) on March 23, 2010, created an abbreviated licensure
pathway for biological products demonstrated to be biosimilar to or
interchangeable with an FDA-licensed reference product. Section 351(k)
of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)), added by
the BPCI Act, sets forth the requirements for an application for a
proposed biosimilar product and an application or supplement for a
proposed interchangeable product. Under section 351(k) of the PHS Act,
a

[[Page 34142]]

proposed biological product that is demonstrated to be biosimilar to a
reference product can rely on certain existing scientific knowledge
about the safety, purity, and potency of the reference product to
support licensure, and this is reflected in the approach to biosimilar
product labeling.
In this guidance, FDA outlines its recommendations for biosimilar
product labeling. A demonstration of biosimilarity means, among other
things, that FDA has determined that there are no clinically meaningful
differences between the proposed product and the reference product in
terms of safety, purity, and potency. Accordingly, biosimilar
applicants should incorporate relevant data and information from the
reference product labeling, with appropriate modifications as
recommended in the guidance.
This guidance finalizes the draft guidance issued on April 4, 2016.
Changes made to the guidance took into consideration the comments
received, as well as requests regarding the requirements for and/or
contents of biosimilar labeling made in the following citizen
petitions: FDA-2015-P-2000 (submitted by AbbVie, Inc.), FDA-2015-P-4529
(submitted by a group of institutional investors including the United
Auto Workers (UAW) Retiree Medical Benefits Trust), and FDA-2015-P-0776
(submitted by the Pharmaceutical Research and Manufacturers of America
and the Biotechnology Industry Organization) (these citizen petitions
are available at https://www.regulations.gov). Editorial changes were
made primarily for clarification.
In the Federal Register of April 4, 2016 (81 FR 19194), FDA
announced the availability of the draft guidance for industry
``Labeling for Biosimilar Products.'' FDA requested comment on whether
FDA-approved patient labeling (e.g., Patient Information, Medication
Guide, and Instructions for Use) should include a biosimilarity
statement similar to the statement described in section IV.C.1 of the
draft guidance. Several comments agreed with inclusion of the
biosimilarity statement; one comment disagreed. FDA considered the
comments received, but decided not to recommend inclusion of a
biosimilarity statement in FDA-approved patient labeling at this time.
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 ``Labeling for Biosimilar 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. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

This 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. 3501-3520). The
collections of information for the submission of a biologics license
application 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 201.57 for the submission of labeling have been
approved under OMB control number 0910-0572; the collections of
information in 21 CFR part 208 for Medication Guides have been approved
under OMB control number 0910-0393; the collections of information in
21 CFR 312.47 for meetings with FDA have been approved under OMB
control number 0910-0014; the collections of information in 21 CFR part
600 for the submission of adverse experience reporting for licensed
biological products and general records have been approved under OMB
control number 0910-0308; and the collections of information in 21 CFR
part 601 for the submission of labeling in a biologics license
application or supplement to a biologics license application have been
approved under OMB control number 0910-0338.

III. Electronic Access

Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

Dated: July 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15391 Filed 7-18-18; 8:45 am]
BILLING CODE 4164-01-P

Document Created: 2018-07-19 01:35:22
Document Modified: 2018-07-19 01:35:22

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		The announcement of the guidance is published in the Federal Register on July 19, 2018.
Contact		Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993, 301-796- 1042; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911.
FR Citation		83 FR 34141

83 FR 34141 - Labeling for Biosimilar Products; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 139 (July 19, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration