
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96010-96011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31511]



[[Page 96010]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0234]


Clinical Pharmacology Data To Support a Demonstration of 
Biosimilarity to a Reference Product; 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 guidance for industry entitled ``Clinical 
Pharmacology Data to Support a Demonstration of Biosimilarity to a 
Reference Product.'' This guidance is to assist the pharmaceutical 
industry and other investigators engaged in biosimilar product 
development in determining the clinical pharmacology data necessary for 
evaluation of a proposed biosimilar product. This guidance finalizes 
the draft guidance with the same name issued in May 2014. This guidance 
is one in a series of guidances that FDA is developing to implement the 
Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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-2014-D-0234 for ``Clinical Pharmacology Data To Support a 
Demonstration of Biosimilarity to a Reference Product; 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 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 to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), 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. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-2500; 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 guidance for industry 
entitled ``Clinical Pharmacology Data to Support a Demonstration of 
Biosimilarity to a Reference Product.'' This guidance is intended to 
assist the pharmaceutical industry and other investigators engaged in 
biosimilar product development with the design and use of clinical 
pharmacology data necessary for evaluation of a proposed biosimilar 
product. This guidance provides recommendations on how clinical 
pharmacology studies that assess the presence or absence of clinically 
meaningful differences between the proposed biosimilar product and the 
U.S.-licensed reference product should be conducted and analyzed to 
address questions arising during biosimilar product development.

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    Clinical pharmacology studies are part of a stepwise approach for 
developing the data and information needed to support a demonstration 
of biosimilarity. These studies can reduce the residual uncertainty in 
assessing the biosimilarity between a proposed biosimilar product and 
reference product and inform the design of subsequent clinical trials 
to assess clinically meaningful differences. This guidance is intended 
to assist sponsors in designing such studies in support of applications 
submitted under section 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)), as added by the BPCI Act.\1\ In particular, this 
guidance discusses certain critical considerations for using clinical 
pharmacology testing to support biosimilarity, approaches for 
developing the appropriate clinical pharmacology database to support a 
demonstration of biosimilarity, and the utility of modeling and 
simulation for designing and analyzing clinical trials. Scientific 
principles described in the guidance may also be informative for the 
development of certain biological products under section 505(b)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)).
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    \1\ The BPCI Act was enacted as part of the Patient Protection 
and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
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    On May 14, 2014, FDA issued a notice announcing the availability of 
a draft guidance with the same name as the current guidance to solicit 
comments from the public (79 FR 27622). After carefully reviewing 
received comments and in light of increased regulatory experience and 
the evolution of the science in biosimilar product development and 
evaluation, FDA has finalized that guidance with certain changes. These 
changes are for clarity, however, and are not substantive.
    This guidance is one in a series that FDA is developing to 
implement the BPCI Act and is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on conducting clinical pharmacology studies 
in support of proposed 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

    The guidance refers to previously approved collections of 
information that 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 collection of information submitted under section 351(k) 
applications for biosimilars is approved under OMB control number 0910-
0719. The collection of information submitted under 21 CFR part 312 is 
approved under OMB control number 0910-0014.

III. Electronic Access

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

    Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31511 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P


