[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Previous guidance Current guidance
Q&A category Q&A Nos. location location
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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