
[Federal Register Volume 79, Number 93 (Wednesday, May 14, 2014)]
[Notices]
[Pages 27622-27623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11053]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Clinical Pharmacology Data To 
Support a Demonstration of Biosimilarity to a Reference Product; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Clinical 
Pharmacology Data to Support a Demonstration of Biosimilarity to a 
Reference Product.'' This guidance is intended to assist sponsors in 
developing a clinical pharmacology program to support a decision that a 
proposed therapeutic biological product is biosimilar to, that is not 
clinically meaningfully different from, its reference product. 
Specifically, the guidance discusses some of the overarching concepts 
related to clinical pharmacology studies for biosimilar products, 
approaches for developing the appropriate clinical pharmacology 
database, and the utility of modeling and simulation for designing 
clinical trials. This draft guidance is one in a series of guidances 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: 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 12, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or 
Office of Communication, Outreach, and Development (HFM-40), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. 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draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

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, email: sandra.benton@fda.hhs.gov; or Stephen Ripley, Center 
for Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Clinical Pharmacology Data to Support a Demonstration of 
Biosimilarity to a Reference Product.'' Clinical pharmacology studies 
are part of a stepwise approach to develop the data and information 
needed to support a demonstration of biosimilarity. Adequate and well-
conducted clinical pharmacology studies can address the residual 
uncertainty in biosimilarity assessment from clinical perspectives and 
inform the design of subsequent studies to assess clinically meaningful 
differences between the biosimilar and the reference products. The 
draft guidance discusses some critical considerations related to 
clinical pharmacology testing for biosimilar products, approaches for 
developing the appropriate clinical pharmacology database, and the 
utility of modeling and simulation for designing clinical trials. In 
its description of how to design and use clinical pharmacology studies 
to add to the totality of evidence that a proposed biological product 
is biosimilar to its reference product, the draft guidance is meant 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)). Scientific principles described in the draft 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).
    This draft 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 draft guidance, when 
finalized, will represent the Agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget 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. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments to 
the Division of Dockets Management (see ADDRESSES). It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

IV. Electronic Access

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

[[Page 27623]]

gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
default.htm, or http://www.regulations.gov.

    Dated: May 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11053 Filed 5-13-14; 8:45 am]
BILLING CODE 4160-01-P


