
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19194-19195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Labeling for Biosimilar Products; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Labeling 
for Biosimilar Products.'' This draft guidance is intended to assist 
applicants in developing draft prescription drug 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). This draft guidance provides an 
overview of FDA's recommendations for labeling for biosimilar products 
licensed under the Public Health Service Act (PHS Act).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 3, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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; Draft Guidance 
for Industry; Availability.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 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. 51, Rm. 6340, 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. 
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 ``Labeling for Biosimilar Products.'' The Biologics Price 
Competition and Innovation Act of 2009 (BCPI 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

[[Page 19195]]

licensure pathway for biological products demonstrated to be biosimilar 
to or interchangeable with a reference product. Section 351(k) of the 
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 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 draft 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 product-specific 
modifications as described in the draft guidance.
    We invite comment on the draft guidance, including whether 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.
    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 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.

II. The 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 (PRA) of 1995 (44 U.S.C. 3501-3520). 
The collections of information under 21 CFR part 601 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 under 21 CFR 201.57 for the submission of labeling have 
been approved under OMB control number 0910-0572; the collections of 
information under 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 under 21 CFR part 600 for the submission of 
MedWatch reporting forms (FDA Form 3500 and FDA Form 3500A) have been 
approved under OMB control number 0910-0291.

III. Electronic Access

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

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07611 Filed 4-1-16; 8:45 am]
 BILLING CODE 4164-01-P


