[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Pages 8885-8886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0611]


Draft Guidance for Industry on Biosimilars: Questions and Answers 
Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009; 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availability of a draft guidance for industry entitled ``Biosimilars: 
Questions and Answers Regarding Implementation of the Biologics Price 
Competition and Innovation Act of 2009.'' This draft guidance is 
intended to provide answers to common questions from sponsors 
interested in developing proposed biosimilar products, biologics 
license application (BLA) holders, and other interested parties 
regarding FDA's interpretation of 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 16, 2012. Submit either electronic or written 
comments on the proposed collection of information by April 16, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist the 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

[[Page 8886]]


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, 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 ``Biosimilars: Questions and Answers Regarding Implementation 
of the Biologics Price Competition and Innovation Act of 2009.'' This 
draft guidance provides answers to common questions from sponsors 
interested in developing proposed biosimilar products, BLA holders, and 
other interested parties regarding FDA's interpretation of the BPCI 
Act.
    The BPCI Act, enacted as part of the Patient Protection and 
Affordable Care Act (Pub. L. 111-148) on March 23, 2010, created an 
abbreviated licensure pathway under section 351(k) of the Public Health 
Service Act (42 U.S.C. 262(k)) for biological products demonstrated to 
be biosimilar to, or interchangeable with, an FDA-licensed biological 
reference product. This draft guidance describes FDA's current 
interpretation of certain statutory requirements added by the BPCI Act 
and includes questions and answers (Q&As) in the following categories:

 Biosimilarity or Interchangeability
 Provisions Related to Requirement to Submit a BLA for a 
``Biological Product''
 Exclusivity

The Q&A format is intended to promote transparency and facilitate 
development programs for proposed biosimilar products by addressing 
questions that may arise in the early stages of development. In 
addition, these Q&As respond to questions the Agency has received from 
prospective BLA and new drug application (NDA) applicants regarding the 
appropriate statutory authority under which certain products will be 
regulated.
    FDA intends to update this guidance to include additional Q&As as 
appropriate and intends to post information by Q&A number on FDA's Web 
site regarding the publication date of draft guidance Q&As for comment, 
the comment period, and the publication date of final guidance Q&As.
    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 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

III. The Paperwork Reduction Act

    This draft guidance describes information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520). In 
particular, the draft guidance refers to information collections 
related to the submission of a 351(k) application. In accordance with 
the PRA, FDA is soliciting public comment, in a separate document 
published elsewhere in this issue of the Federal Register (see ``Agency 
Information Collection Activities; Proposed Collection; Comment 
Request; General Licensing Provisions; Section 351(k) Biosimilar 
Applications'') on the information collection associated with the 
submission of a 351(k) application. FDA will also seek OMB approval for 
this information collection.
    In addition, this draft guidance references other information 
collections that are already approved by OMB and are not expected to 
change as a result of the draft guidance. This includes information 
collections related to the submission of (1) an investigational NDA, 
which is covered under 21 CFR part 312 and approved under OMB control 
number 0910-0014; (2) an NDA, which is covered under 21 CFR 314.50 and 
approved under OMB control number 0910-0001; (3) a biologics license 
application, which is covered under 21 CFR part 601 and approved under 
OMB control number 0910-0338; and (4) labeling, which is covered under 
21 CFR 201.57 and approved under OMB control number 0910-0572.
    The draft guidance also discusses the retention of reserve samples 
of the biological products used in comparative clinical pharmacokinetic 
and/or pharmacodynamic studies intended to support a proposed 351(k) 
application. Such reserve samples are samples of products or other 
physical objects exempt under 5 CFR 1320.3(h)(2), and thus not 
considered ``information'' as that term is defined under the PRA.

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: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3549 Filed 2-14-12; 8:45 am]
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