[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Page 22693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09220]



[[Page 22693]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-0178]


Guidance for Industry on Interpreting Sameness of Monoclonal 
Antibody Products Under the Orphan Drug Regulations; 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 guidance for industry entitled ``Interpreting 
Sameness of Monoclonal Antibody Products Under the Orphan Drug 
Regulations.'' The purpose of this guidance is to provide sponsors and 
manufacturers FDA's current thinking on the criteria by which two 
monoclonal antibody products would be considered the same under the 
Orphan Drug Act and implementing regulations.

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

ADDRESSES: 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, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, 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.
    Submit electronic comments on the 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: Marjorie Shapiro, Center for Drug 
Evaluation and Research (HFD-123), Food and Drug Administration, 9000 
Rockville Pike, Bethesda, MD 20892, 301-827-0710, or Henry Startzman, 
Office of Orphan Products Development, Office of Special Medical 
Programs, Food and Drug Administration, 10903 New Hampshire Ave, Silver 
Spring, MD 20993, 301-796-8660.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Interpreting Sameness of Monoclonal Antibody Products Under 
the Orphan Drug Regulations.''
    On July 26, 1999 (64 FR 40381), FDA announced the availability of 
the draft version of this guidance. The public comment period closed on 
October 25, 1999. A number of comments were received from the public, 
all of which the Agency considered carefully as it finalized the 
guidance and made appropriate changes. Any changes to the guidance were 
minor and made to clarify statements in the draft guidance.
    In the Federal Register of December 29, 1992 (57 FR 62076), FDA 
published the orphan drug regulations final rule, and on June 12, 2013 
(78 FR 35117) the Agency finalized certain amendments to the final rule 
in order to clarify regulatory provisions and make minor improvements 
to address issues that have arisen since 1992. The final rule 
established in part 316 (21 CFR part 316) regulations that prescribe 
certain incentives for the development of ``orphan drugs'', drugs which 
are intended for use in rare diseases or conditions. One of the 
incentives for orphan drug development is to obtain exclusive approval 
for the pioneer product for a period of 7 years during which no 
approval will be given to a subsequent sponsor of the same drug product 
for the same indication unless it proves to be clinically superior, as 
defined in Sec.  316.3(b)(3). In determining whether or not two 
products would be considered the same, FDA recognized that different 
criteria were necessary for macromolecules versus small molecules 
(Sec.  316.3(b)(13)).
    Macromolecules include a variety of structures including proteins, 
nucleic acids, carbohydrates and closely related, complex, partly 
definable drugs such as live viral vaccines. The current definition of 
sameness for protein drugs (Sec.  316.3(b)(13)(ii)(A)), however, does 
not consider the unique nature of antibodies. This final document is 
intended to describe FDA's thinking on the criteria by which two 
monoclonal antibody products would be considered the same under the 
Orphan Drug Act and its implementing regulations.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on Interpreting Sameness of Monoclonal 
Antibody Products Under the Orphan Drug Regulations. 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. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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.

III. The 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) and 
have been approved under OMB control numbers 0910-0167 (21 CFR part 
316), 0910-0001 (21 CFR part 314), and 0910-0014 (21 CFR part 312).

IV. Electronic Access

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

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09220 Filed 4-22-14; 8:45 am]
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