[Federal Register Volume 79, Number 93 (Wednesday, May 14, 2014)]
[Notices]
[Pages 27622-27623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11053]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Clinical Pharmacology Data To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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Clinical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 This draft guidance is one in a series of guidances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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 12, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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draft guidance document.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: [email protected]; 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