[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24259-24260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Biosimilars: Questions and Answers Regarding Implementation of 
the Biologics Price Competition and Innovation Act of 2009; Guidance 
for Industry; 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 ``Biosimilars: 
Questions and Answers Regarding Implementation of the Biologics Price 
Competition and Innovation Act of 2009.'' This 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 finalizes several questions and answers 
(Q&As) from the draft guidance entitled ``Biosimilars: Questions and 
Answers Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009'' issued February 15, 2012.

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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993; or Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Suite 200N, 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 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: 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 guidance for industry 
entitled ``Biosimilars: Questions and Answers Regarding Implementation 
of the

[[Page 24260]]

Biologics Price Competition and Innovation Act of 2009.'' This 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 (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 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''
     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 a 
revised draft guidance and this final guidance. This guidance describes 
the status of the draft guidance Q&As provided in Revision 1 of the 
draft guidance entitled ``Biosimilars: Additional Questions and Answers 
Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009,'' and the status of the final guidance Q&As 
that are included in this guidance. FDA intends to update these 
guidances to include additional Q&As as appropriate.
    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 ``Biosimilars: Questions and Answers 
Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009.'' 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. The Paperwork Reduction Act of 1995

    This guidance refers to information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act (PRA) of 1995 (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 number 0910-0014. The 
submission of an NDA is covered under 21 CFR 314.50 and approved under 
OMB control number 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 number 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. In the Federal Register of 
April 1, 2013 (78 FR 19492), FDA published a notice announcing the 
availability of a draft guidance for industry entitled ``Formal 
Meetings Between the FDA and Biosimilar Biological Product Sponsors or 
Applicants.'' The notice contained an analysis of the information 
collection burden resulting from the draft guidance, and will be 
submitted to OMB for approval before issuance of the final guidance.

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: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10064 Filed 4-29-15; 8:45 am]
 BILLING CODE 4164-01-P