[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Pages 34141-34142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15391]



[[Page 34141]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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finalizes the draft guidance issued on April 4, 2016.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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.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 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