[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Notices]
[Pages 45448-45450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18169]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1165]
Draft Guidance for Industry on Reference Product Exclusivity for
Biological Products Filed Under Section 351(a) of the Public Health
Service Act; 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availability of a draft guidance for industry entitled ``Reference
Product Exclusivity for Biological Products Filed Under Section 351(a)
of the PHS Act.'' This draft guidance is intended to assist sponsors
developing biological products, sponsors holding biologics license
applications (BLAs), and other interested parties in providing
information and data that will help the Agency determine the date of
first licensure for a reference product under 351(k)(7)(C) of the
Public Health Service Act (PHS Act), as added by the Biologics Price
Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends
the PHS Act and other statutes to create an abbreviated licensure
pathway for biological products shown to be biosimilar to, or
interchangeable with, an FDA-licensed biological reference product.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 6, 2014. Submit either electronic or written
comments concerning the proposed collection of information by October
6, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, 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.
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-
796-1042; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), 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 ``Reference Product Exclusivity for Biological Products Filed
Under Section 351(a) of the PHS Act.'' This draft guidance is intended
to assist sponsors who are developing biological products, sponsors of
BLAs, and other interested parties in providing information that will
help the Agency determine the date of first licensure for a reference
product under 351(k)(7)(C) of the Public Health Service Act (PHS Act)
as added by the Biologics Price Competition and Innovation Act of 2009
(BPCI Act).
The BPCI Act amends the PHS Act and other statutes to create an
abbreviated licensure pathway for biological products shown to be
biosimilar to, or interchangeable with, an FDA-licensed biological
reference product (see sections 7001 through 7003 of the Patient
Protection and Affordable Care Act (Pub. L. 111-148)). Section
351(k)(7) of the PHS Act, entitled ``Exclusivity for Reference
Product,'' describes reference product exclusivity, the period of time
in which a 351(k) sponsor is not permitted to submit and FDA is not
permitted to license a 351(k) application that references a reference
product, the single biological product licensed under section 351(a) of
the PHS Act against which a biological product is evaluated in a 351(k)
application. Under this section, exclusivity for the reference product
is described in terms
[[Page 45449]]
of a prohibition on acceptance or approval of an application for a
biosimilar or interchangeable product for a period of time starting
from the date of first licensure. Specifically, approval of a 351(k)
application may not be made effective until 12 years after the date of
first licensure of the reference product which under the statute
excludes the date of licensure of supplements and certain other
applications. A 351(k) application for a biosimilar or interchangeable
biological product cannot be submitted for review until 4 years after
the date on which the reference product was first licensed under
section 351(a) of the PHS Act.
Determining the date of first licensure for a reference product, in
turn, determines whether a particular biological product qualifies for
a period of exclusivity under 351(k)(7) of the PHS Act and the date on
which such exclusivity, if any, will expire. Making this determination
can present unique challenges given the requirements of section
351(k)(7) of the PHS Act. These are made more acute because of the
scientific and technical complexities that may be associated with the
larger and typically more complex structures of biological products as
compared with small molecule drugs, as well as the processes by which
such biological products are made. Therefore, the 351(a) applicant may
provide information to FDA, such as that described in this guidance or
other relevant information, to assist FDA with its analysis of the date
of first licensure for a biological product under section 351(k)(7) of
the PHS Act.
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 Agency's current thinking on determining
the date of first licensure for biological products filed under section
351(a) of the PHS Act. 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 electronic comments regarding
this document 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.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR 314.50 and 21 CFR part 601 (BLA) have been approved under OMB
control numbers 0910-0001 and 0910-0338, respectively. The general
licensing provisions under section 351(k) (biosimilar applications) of
the BPCI Act have been approved under OMB control number 0910-0719.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Draft Guidance for Industry on Reference Product Exclusivity
for Biological Products Filed Under Section 351(a) of the PHS Act.
Description of Respondents: Respondents to the proposed collection
of information include sponsors developing biological products and
sponsors holding BLAs.
Burden Estimate: The draft guidance proposes a new collection of
information by requesting information and data from sponsors to assist
FDA in determining the date of first licensure for a reference product
filed under section 351(a) of the PHS Act described under section
351(k)(7) of the PHS Act as added by the BPCI Act. The proposed
collection of information includes information that would describe and
explain how a proposed product is structurally the same as or different
from any previously licensed biological product, along with supporting
information that describes how such modification results in a change in
safety, purity, or potency of the product. FDA recommends that the
sponsor include information as described in the draft guidance at the
time the 351(a) application is submitted or, in the case of a
previously approved 351(a) application, as a supplement to the
application. Alternatively, this information may be submitted as an
amendment to the 351(a) application. A summary of the recommended
information includes the following: (1) A list of all licensed
biological products that are structurally related to the biological
product that is the subject of the 351(a) application being considered;
(2) of those licensed biological products identified in item 1, the
identification of the products for which the sponsor or one of the
sponsor's affiliates, including any licensors, predecessors in
interest, successors in interest, or related entities, are the current
or previous license holder; (3) description of the structural
differences between the proposed product and any products identified in
item 2; and (4) description of the change in safety, purity, and/or
potency between the proposed product and any products identified in
item 2. The proposed collection of information also includes any other
information and data that would assist FDA in making a determination of
the date of first licensure for biological products and BLAs as
described under section 351(k)(7) of the PHS Act. FDA estimates the
burden of this collection of information as follows:
[[Page 45450]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Reporting activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Information for Determination of 10 1 10 150 1,500
the Date of First Licensure.....
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
As indicated in table 1 of this document, FDA estimates that it
will receive a total of approximately 10 requests annually for
determination of the date of first licensure of a 351(a) product under
351(k)(7) of the PHS Act. The average burden per response (hours) is
based on FDA experience with similar information collection
requirements.
IV. Electronic Access
Persons with access to the Internet may obtain the document 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: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18169 Filed 8-4-14; 8:45 am]
BILLING CODE 4164-01-P