[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27321-27322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Biosimilars: Additional Questions and Answers Regarding 
Implementation of the Biologics Price Competition and Innovation Act of 
2009; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a revised draft guidance for industry entitled 
``Biosimilars: Additional 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 This draft guidance is intended to provide answers to common 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). This guidance 
revises the draft guidance entitled ``Biosimilars: Questions and 
Answers Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009,'' issued February 15, 2012, to provide new and 
revised questions and answers (Q&As).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 13, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002, or Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), 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INFORMATION section for electronic access to the draft guidance 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, 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 revised draft guidance for 
industry entitled ``Biosimilars: Additional 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. This guidance revises 
the draft guidance entitled ``Biosimilars: Questions and Answers 
Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009,'' issued February 15, 2012, to provide new and 
revised Q&As. It also includes certain original Q&As that have not yet 
been finalized.
    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 (the PHS Act) (42 U.S.C. 262(k)) for biological products 
demonstrated to be biosimilar to, or interchangeable with, an FDA-
licensed reference product. This draft guidance describes FDA's current 
interpretation of certain statutory requirements added by the BPCI Act 
and includes Q&As in the following categories:
     Biosimilarity or Interchangeability
     Provisions Related to Requirement to Submit a BLA for a 
``Biological Product''

[[Page 27322]]

     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.
    In the Federal Register of February 15, 2012 (77 FR 8885), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``Biosimilars: Questions and Answers Regarding Implementation 
of the Biologics Price Competition and Innovation Act of 2009.'' 
Although interested parties can comment on any guidance at any time, to 
ensure that the Agency considered comments on the draft guidance before 
beginning work on the final version of the guidance, FDA requested that 
interested parties submit comments by April 16, 2012. FDA's 
consideration of these comments, among other things, is reflected in 
this revised draft guidance (which provides new and revised Q&As) and 
the final guidance. This revised draft guidance describes the status of 
the draft guidance Q&As provided in this revised draft guidance and the 
status of the final guidance Q&As that are included in the guidance 
entitled ``Biosimilars: Questions and Answers Regarding Implementation 
of the Biologics Price Competition and Innovation Act of 2009.'' FDA 
intends to update these guidances to include additional Q&As as 
appropriate.
    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 current thinking of FDA on this topic. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it 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. The Paperwork Reduction Act of 1995

    This draft guidance refers to information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The submission of an investigational new drug application is 
covered under 21 CFR part 312 and approved under OMB Control No. 0910-
0014. The submission of an NDA is covered under 21 CFR 314.50 and 
approved under OMB Control No. 0910-0001. The submission of a BLA under 
section 351(a) of the PHS Act is covered under part 601 (21 CFR part 
601) and approved under OMB Control No. 0910-0338. The submission of a 
BLA under section 351(k) of the PHS Act is covered under part 601 and 
approved under OMB control number 0910-0719.

IV. Electronic Access

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

    Dated: May 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11528 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P