
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63898-63900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


New and Revised Draft Q&As on Biosimilar Development and the 
Biologics Price Competition and Innovation Act (Revision 2); Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``New and 
Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 
2).'' 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 This draft guidance document revises the draft guidance document 
entitled ``Biosimilars: Additional Questions and Answers Regarding 
Implementation of the Biologics Price Competition and Innovation Act of 
2009,'' issued May 13, 2015, to provide new and revised Q&As.

DATES: Submit either electronic or written comments on the draft 
guidance by February 11, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 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 ``New and Revised Draft Q&As on Biosimilar 
Development and the BPCI Act (Revision 2); Draft 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

[[Page 63899]]

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 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 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 draft 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 draft guidance for industry 
entitled ``New and Revised Draft Q&As on Biosimilar Development and the 
BPCI Act (Revision 2).'' 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 (42 U.S.C. 262(k)) 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 to include additional Q&As as appropriate.
    This draft guidance is a companion to the final guidance entitled 
``Questions and Answers on Biosimilar Development and the BPCI Act.'' 
In this pair of guidance documents, FDA issues each Q&A in draft form 
in this draft guidance, receives comments on the draft Q&A, and, as 
appropriate, moves the Q&A to the final guidance, after reviewing 
comments and incorporating suggested changes to the Q&A, when 
appropriate. Thus, this draft guidance contains Q&As distributed for 
comment purposes only and includes new Q&As, as well as revisions to 
Q&As that appeared in previous versions of the draft or final guidance 
documents. The final guidance contains Q&As that have been through the 
public comment process and reflects FDA's current thinking on the 
topics described. 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 another FDA guidance document.
    FDA has maintained the original numbering of the Q&As used in the 
April 2015 final guidance (``Biosimilars: Questions and Answers 
Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009'') and the May 2015 draft guidance 
(``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.
                                    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.

[[Page 63900]]

 
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 draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The Q&As in this draft 
guidance, when finalized, will appear in the final guidance, and the 
final guidance will represent the current thinking of FDA on the Q&As 
posed in the ``New and Revised Draft Q&As on Biosimilar Development and 
the BPCI Act (Revision 2).'' 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 guidance 
for industry entitled ``Questions and Answers on Biosimilar Development 
and the BPCI Act.''

II. Paperwork Reduction Act of 1995

    This draft 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 and 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 
and 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 
``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 draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26852 Filed 12-11-18; 8:45 am]
 BILLING CODE 4164-01-P


