[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63900-63902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Biosimilars: Questions and Answers on Biosimilar Development and 
the Biologics Price Competition and Innovation Act of 2009; Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Questions 
and Answers on Biosimilar Development and the BPCI Act.'' The question 
and answer (Q&A) format is intended to inform prospective applicants 
and facilitate the development of proposed biosimilars and proposed 
interchangeable biosimilars, as well as to describe FDA's 
interpretation of certain statutory requirements added by the Biologics 
Price Competition and Innovation Act of 2009 (BPCI Act). This guidance 
document revises the final guidance document entitled ``Biosimilars: 
Questions and Answers Regarding Implementation of the Biologics Price 
Competition and Innovation Act of 2009'' issued April 28, 2015.

DATES: The announcement of the guidance is published in the Federal 
Register on December 12, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for

[[Page 63901]]

information submitted, marked and identified, as confidential, if 
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-D-0611 for ``Questions and Answers on Biosimilar Development 
and the BPCI Act; Guidance for Industry.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 20993-0002, or the Office of 
Communication, Outreach and Development, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993, 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 final guidance for industry 
entitled ``Questions and Answers on Biosimilar Development and the BPCI 
Act.'' The Q&A format is intended to inform prospective applicants and 
facilitate the development of proposed biosimilars and proposed 
interchangeable biosimilars, as well as to describe FDA's 
interpretation of certain statutory requirements added by the BPCI Act.
    The BPCI Act amended the Public Health Service Act (PHS Act) and 
other statutes to create an abbreviated licensure pathway in section 
351(k) of the PHS Act 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)). FDA believes that guidance for 
industry that provides answers to commonly asked questions regarding 
FDA's interpretation of the BPCI Act will enhance transparency and 
facilitate the development and approval of biosimilar and 
interchangeable products. FDA intends to update this guidance document 
to include additional Q&As as appropriate.
    This final guidance document is a companion to the draft guidance 
document entitled ``New and Revised Draft Q&As on Biosimilar 
Development and the BPCI Act (Revision 2).'' In this pair of guidance 
documents, FDA issues each Q&A in draft form in the draft guidance 
document, receives comments on the draft Q&A, and, as appropriate, 
moves the Q&A to this final guidance document, after reviewing comments 
and incorporating suggested changes to the Q&A, when appropriate. This 
final guidance document contains Q&As that have been through the public 
comment process and reflects FDA's current thinking on the topics 
described. This guidance document revises the final guidance document 
entitled ``Biosimilars: Questions and Answers Regarding Implementation 
of the Biologics Price Competition and Innovation Act of 2009'' to 
clarify and update certain Q&As and to add new Q&As. For certain Q&As, 
FDA has updated the Q&A by referring the reader to a separate guidance 
document that provides additional information on the topic. In 
addition, a Q&A may be withdrawn and removed from the Q&A guidance 
documents if, for instance, the issue addressed in the Q&A has been 
addressed in a separate FDA guidance document. For example, Q&A I.11 
has been withdrawn as the issues addressed in that question are 
addressed in the guidance for industry entitled ``Scientific 
Considerations in Demonstrating Biosimilarity to a Reference Product.''
    FDA has maintained the original numbering of the Q&As used in the 
April 2015 final guidance document (``Biosimilars: Questions and 
Answers Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009'') and May 2015 draft guidance document 
(``Biosimilars: Additional Questions and Answers Regarding 
Implementation of the Biologics Price Competition and Innovation Act of 
2009'').

                         Table 1--Status of Draft Guidance Q&As and Final Guidance Q&As
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                                                                  Previous guidance         Current guidance
           Q&A category                     Q&A  Nos.                 location                  location
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Part I. Biosimilarity or            Q.I.1...................  Final...................  Final
 Interchangeability.

[[Page 63902]]

 
                                    Q.I.2...................  Final...................  Final.
                                    Q.I.3...................  Final...................  Final.
                                    Q.I.4...................  Final...................  Final.
                                    Q.I.5...................  Final...................  Final.
                                    Q.I.6...................  Final...................  Final.
                                    Q.I.7...................  Final...................  Final.
                                    Q.I.8...................  Final...................  Final.
                                    Q.I.9...................  Draft...................  Final.
                                    Q.I.10..................  Draft...................  Final.
                                    Q.I.11..................  Final...................  Withdrawn.
                                    Q.I.12..................  Final...................  Draft.
                                    Q.I.13..................  Draft...................  Final.
                                    Q.I.14..................  Draft...................  Final.
                                    Q.I.15..................  Final...................  Final.
                                    Q.I.16..................  Draft...................  Draft.
                                    Q.I.17..................  Draft...................  Final.
                                    Q.I.18..................  Draft...................  Final.
                                    Q.I.19..................  Draft...................  Final.
                                    Q.I.20..................                            Draft.
                                    Q.I.21..................                            Draft.
                                    Q.I.22..................                            Draft.
                                    Q.I.23..................                            Draft.
                                    Q.I.24..................                            Draft.
Part II. Provisions Related to      Q.II.1..................  Final...................  Draft.
 Requirements to Submit a
 Biologics License Application
 (BLA) for a ``Biological
 Product''.
                                    Q.II.2..................  Final...................  Final.
                                    Q.II.3..................  Draft...................  Final.
Part III. Exclusivity.............  Q.III.1.................  Draft...................  Final.
                                    Q.III.2.................  Final...................  Final.
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    This guidance finalizes certain Q&As that were included in the 
draft guidance issued on May 13, 2015. FDA considered written comments 
the Agency received regarding these Q&As, and made changes to the Q&As, 
as appropriate. Editorial changes were made primarily for 
clarification.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Questions and Answers on Biosimilar 
Development and the BPCI Act.'' 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. This guidance is not subject to Executive 
Order 12866.
    FDA is announcing, in a separate document published elsewhere in 
this issue of the Federal Register, the availability of the draft 
guidance for industry entitled ``New and Revised Draft Q&As on 
Biosimilar Development and the BPCI Act (Revision 2).''

II. 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). The 
collections of information in 21 CFR part 312 for submission of an 
investigational new drug application have been approved under OMB 
control number 0910-0014. The collections of information in 21 CFR 
314.50 for submission of a new drug application have been approved 
under OMB control number 0910-0001. The collections of information in 
section 351(a) of the PHS Act under part 601 (21 CFR part 601) for 
submission of a BLA have been approved under OMB control number 0910-
0338. The collections of information in section 351(k) of the PHS Act 
under part 601 for submission of a BLA have been approved under OMB 
control number 0910-0719. The collections of information for submission 
of a meeting package to the appropriate review division with the 
meeting request as described in the draft guidance for industry 
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants 
of BsUFA Products'' have been approved under OMB control number 0910-
0802.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26853 Filed 12-11-18; 8:45 am]
 BILLING CODE 4164-01-P