Interpretation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability, 63896-63898 [2018-26854]
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63896
Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
and regulations. This guidance is not
subject to Executive Order 12866.
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This draft guidance refers to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 collection of
information in 21 CFR part 314 has been
approved under OMB control number
0910–0001; the collection of
information in 21 CFR parts 601 and
610 has been approved under OMB
control number 0910–0338; the
collection of information in 21 CFR
600.80 through 600.90 has been
approved under OMB control number
0910–0308; and the collection of
information in 21 CFR 201.56, 201.57,
and 201.80 has been approved under
OMB control number 0910–0572. In
addition, the collections of information
for applications submitted under section
351(k) of the PHS Act (42 U.S.C. 262(k))
have been approved under OMB control
number 0910–0719.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26855 Filed 12–11–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4750]
Interpretation of the ‘‘Deemed To Be a
License’’ Provision of the Biologics
Price Competition and Innovation Act
of 2009; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
amozie on DSK3GDR082PROD with NOTICES1
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Interpretation of the ‘Deemed To Be a
License’ Provision of the Biologics Price
Competition and Innovation Act of
2009.’’ This guidance describes FDA’s
SUMMARY:
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18:39 Dec 11, 2018
Jkt 247001
interpretation of the statutory provision
under which an application for a
biological product approved under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) as of March 23, 2020, will
be deemed to be a license for the
biological product under the Public
Health Service Act (PHS Act) on March
23, 2020. Specifically, this guidance
describes FDA’s interpretation of the
‘‘deemed to be a license’’ provision of
the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) for
biological products that are approved
under the FD&C Act as of March 23,
2020. This guidance also provides
recommendations to sponsors of
proposed protein products intended for
submission in an application that may
not receive final approval under the
FD&C Act on or before March 23, 2020,
to facilitate alignment of product
development plans with FDA’s
interpretation of the transition provision
of the BPCI Act.
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:
PO 00000
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Fmt 4703
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• 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–
2015–D–4750 for ‘‘Interpretation of the
‘Deemed To Be a License’ Provision of
the Biologics Price Competition and
Innovation Act of 2009; Guidance for
Industry; Availability.’’ 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/201523389.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
E:\FR\FM\12DEN1.SGM
12DEN1
Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
‘‘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 to 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:
Janice Weiner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6270,
Silver Spring, MD 20993–0002, 301–
796–3475; 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:
amozie on DSK3GDR082PROD with NOTICES1
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Interpretation of the ‘Deemed To Be a
License’ Provision of the Biologics Price
Competition and Innovation Act of
2009.’’
This guidance describes FDA’s
interpretation of the provision of the
BPCI Act under which an application
for a biological product approved under
section 505 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355) as of March 23, 2020, will be
deemed to be a license for the biological
product under section 351 of the PHS
Act (42 U.S.C. 262) on March 23, 2020.
Specifically, this guidance describes
FDA’s interpretation of the ‘‘deemed to
be a license’’ provision in section
7002(e) of the BPCI Act for biological
products that are approved under
section 505 of the FD&C Act as of March
23, 2020 (the transition date). This
guidance also provides
recommendations to sponsors of
proposed protein products intended for
submission in an application that may
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not receive final approval under section
505 of the FD&C Act on or before March
23, 2020, to facilitate alignment of
product development plans with FDA’s
interpretation of section 7002(e) of the
BPCI Act.
Although the majority of therapeutic
biological products have been licensed
under section 351 of the PHS Act, some
protein products historically have been
approved under section 505 of the FD&C
Act. On March 23, 2010, the BPCI Act
was enacted as part of the Patient
Protection and Affordable Care Act
(Pub. L. 111–148). The BPCI Act
clarified the statutory authority under
which certain protein products will be
regulated by amending the definition of
a ‘‘biological product’’ in section 351(i)
of the PHS Act to include a ‘‘protein
(except any chemically synthesized
polypeptide),’’ and describing
procedures for submission of a
marketing application for a ‘‘biological
product.’’ FDA previously stated its
interpretation of the statutory terms
‘‘protein’’ and ‘‘chemically synthesized
polypeptide’’ in the amended definition
of ‘‘biological product’’ (see FDA’s draft
guidance for industry entitled ‘‘New and
Revised Draft Q&As on Biosimilar
Development and the BPCI Act
(Revision 2),’’ available on FDA’s
website at https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm).
Elsewhere in this issue of the Federal
Register, FDA also has issued a
proposed rule to amend its regulation
that defines ‘‘biological product’’ to
incorporate changes made by the BPCI
Act, and to provide its interpretation of
the statutory terms ‘‘protein’’ and
‘‘chemically synthesized polypeptide.’’
When final, this regulation will codify
FDA’s interpretation of these terms.
The BPCI Act requires that a
marketing application for a ‘‘biological
product’’ (that previously could have
been submitted under section 505 of the
FD&C Act) must be submitted under
section 351 of the PHS Act; this
requirement is subject to certain
exceptions during a 10-year transition
period ending on March 23, 2020 (see
section 7002(e)(1)–(3) and (e)(5) of the
BPCI Act). On March 23, 2020, an
approved application for a biological
product under section 505 of the FD&C
Act shall be deemed to be a license for
the biological product under section 351
of the PHS Act (see section 7002(e)(4) of
the BPCI Act). Among other things,
while section 7002(e)(4) of the BPCI Act
explicitly provides that an approved
application under section 505 of the
FD&C Act shall be deemed to be a
license on March 23, 2020, the statute
does not provide a means for deeming
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an approved new drug application
(NDA) to be an approved biologics
license application (BLA) prior to, or
after, the transition date. Therefore, FDA
interprets section 7002(e) of the BPCI
Act to plainly mean that, on March 23,
2020, only approved NDAs will be
deemed to be BLAs. After March 23,
2020, the Agency will not approve any
application submitted under section 505
of the FD&C Act for a biological product
subject to the transition provision that is
pending or tentatively approved. Such
an application may, for example, be
withdrawn and submitted under section
351(a) or 351(k) of the PHS Act, as
appropriate. In the final guidance, FDA
provides recommendations to minimize
the impact on development programs
for any proposed biological products
intended for submission under section
505 of the FD&C Act that may not be
able to receive final approval by March
23, 2020.
In the Federal Register of March 14,
2016 (81 FR 13373), FDA announced the
availability of the draft of this guidance.
FDA received several comments on the
draft guidance, and those comments
were considered as the guidance was
finalized. This final guidance explains
that FDA interprets section 7002(e) of
the BPCI Act and section 351 of the PHS
Act to mean that an approved NDA for
a biological product that will be deemed
to be ‘‘licensed’’ under section 351(a) of
the PHS Act on March 23, 2020, can be
a reference product for a proposed
biosimilar product or a proposed
interchangeable product (see section
351(i)(4) of the PHS Act). However, a
biological product that was first
approved in an NDA under section 505
of the FD&C Act and deemed ‘‘licensed’’
under section 351(a) of the PHS Act on
March 23, 2020, will not have been
‘‘first licensed under subsection (a)’’ for
purposes of section 351(k)(7) of the PHS
Act. Thus, such a biological product
will not be eligible for exclusivity under
section 351(k)(7)(A) and (B) of the PHS
Act. Moreover, FDA interprets the
limitations on eligibility for reference
product exclusivity in section
351(k)(7)(C) of the PHS Act to apply to
any reference product. The guidance
also clarifies the Agency’s approach to
supplements submitted to an approved
NDA for a biological product before
March 23, 2020, that are pending on the
transition date.
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 ‘‘Interpretation of
the ‘Deemed To Be a License’ Provision
of the Biologics Price Competition and
Innovation Act of 2009.’’ It does not
E:\FR\FM\12DEN1.SGM
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63898
Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
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.
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 collection of information in
21 CFR part 312 has been approved
under OMB control number 0910–0014;
the collection of information in 21 CFR
part 314 has been approved under OMB
control number 0910–0001; the
collection of information in 21 CFR part
601 has been approved under OMB
control number 0910–0338; and the
collection of information for
applications submitted under section
351(k) of the PHS Act has been
approved under OMB control number
0910–0719; the collection of
information in FDA’s guidance for
industry entitled ‘‘Formal Meetings
Between the FDA and Biosimilar
Biological Product Sponsors or
Applicants’’ has been approved under
OMB control number 0910–0802; and
the collection of information in FDA’s
guidance for industry entitled ‘‘Formal
Meetings Between the FDA and
Sponsors or Applicants of PDUFA
Products’’ has been approved under
OMB control number 0910–0429.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
amozie on DSK3GDR082PROD with NOTICES1
[FR Doc. 2018–26854 Filed 12–11–18; 8:45 am]
BILLING CODE 4164–01–P
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Jkt 247001
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.
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:
SUMMARY:
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
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12DEN1.SGM
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Agencies
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63896-63898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26854]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-4750]
Interpretation of the ``Deemed To Be a License'' Provision of 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
``Interpretation of the `Deemed To Be a License' Provision of the
Biologics Price Competition and Innovation Act of 2009.'' This guidance
describes FDA's interpretation of the statutory provision under which
an application for a biological product approved under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be
deemed to be a license for the biological product under the Public
Health Service Act (PHS Act) on March 23, 2020. Specifically, this
guidance describes FDA's interpretation of the ``deemed to be a
license'' provision of the Biologics Price Competition and Innovation
Act of 2009 (BPCI Act) for biological products that are approved under
the FD&C Act as of March 23, 2020. This guidance also provides
recommendations to sponsors of proposed protein products intended for
submission in an application that may not receive final approval under
the FD&C Act on or before March 23, 2020, to facilitate alignment of
product development plans with FDA's interpretation of the transition
provision of the BPCI Act.
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 information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-D-4750 for ``Interpretation of the `Deemed To Be a License'
Provision of the Biologics Price Competition and Innovation Act of
2009; Guidance for Industry; Availability.'' 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
[[Page 63897]]
``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 to 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: Janice Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301-
796-3475; 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 ``Interpretation of the `Deemed To Be a License' Provision of
the Biologics Price Competition and Innovation Act of 2009.''
This guidance describes FDA's interpretation of the provision of
the BPCI Act under which an application for a biological product
approved under section 505 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a
license for the biological product under section 351 of the PHS Act (42
U.S.C. 262) on March 23, 2020. Specifically, this guidance describes
FDA's interpretation of the ``deemed to be a license'' provision in
section 7002(e) of the BPCI Act for biological products that are
approved under section 505 of the FD&C Act as of March 23, 2020 (the
transition date). This guidance also provides recommendations to
sponsors of proposed protein products intended for submission in an
application that may not receive final approval under section 505 of
the FD&C Act on or before March 23, 2020, to facilitate alignment of
product development plans with FDA's interpretation of section 7002(e)
of the BPCI Act.
Although the majority of therapeutic biological products have been
licensed under section 351 of the PHS Act, some protein products
historically have been approved under section 505 of the FD&C Act. On
March 23, 2010, the BPCI Act was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act
clarified the statutory authority under which certain protein products
will be regulated by amending the definition of a ``biological
product'' in section 351(i) of the PHS Act to include a ``protein
(except any chemically synthesized polypeptide),'' and describing
procedures for submission of a marketing application for a ``biological
product.'' FDA previously stated its interpretation of the statutory
terms ``protein'' and ``chemically synthesized polypeptide'' in the
amended definition of ``biological product'' (see FDA's draft guidance
for industry entitled ``New and Revised Draft Q&As on Biosimilar
Development and the BPCI Act (Revision 2),'' available on FDA's website
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm). Elsewhere in this issue of the Federal
Register, FDA also has issued a proposed rule to amend its regulation
that defines ``biological product'' to incorporate changes made by the
BPCI Act, and to provide its interpretation of the statutory terms
``protein'' and ``chemically synthesized polypeptide.'' When final,
this regulation will codify FDA's interpretation of these terms.
The BPCI Act requires that a marketing application for a
``biological product'' (that previously could have been submitted under
section 505 of the FD&C Act) must be submitted under section 351 of the
PHS Act; this requirement is subject to certain exceptions during a 10-
year transition period ending on March 23, 2020 (see section
7002(e)(1)-(3) and (e)(5) of the BPCI Act). On March 23, 2020, an
approved application for a biological product under section 505 of the
FD&C Act shall be deemed to be a license for the biological product
under section 351 of the PHS Act (see section 7002(e)(4) of the BPCI
Act). Among other things, while section 7002(e)(4) of the BPCI Act
explicitly provides that an approved application under section 505 of
the FD&C Act shall be deemed to be a license on March 23, 2020, the
statute does not provide a means for deeming an approved new drug
application (NDA) to be an approved biologics license application (BLA)
prior to, or after, the transition date. Therefore, FDA interprets
section 7002(e) of the BPCI Act to plainly mean that, on March 23,
2020, only approved NDAs will be deemed to be BLAs. After March 23,
2020, the Agency will not approve any application submitted under
section 505 of the FD&C Act for a biological product subject to the
transition provision that is pending or tentatively approved. Such an
application may, for example, be withdrawn and submitted under section
351(a) or 351(k) of the PHS Act, as appropriate. In the final guidance,
FDA provides recommendations to minimize the impact on development
programs for any proposed biological products intended for submission
under section 505 of the FD&C Act that may not be able to receive final
approval by March 23, 2020.
In the Federal Register of March 14, 2016 (81 FR 13373), FDA
announced the availability of the draft of this guidance. FDA received
several comments on the draft guidance, and those comments were
considered as the guidance was finalized. This final guidance explains
that FDA interprets section 7002(e) of the BPCI Act and section 351 of
the PHS Act to mean that an approved NDA for a biological product that
will be deemed to be ``licensed'' under section 351(a) of the PHS Act
on March 23, 2020, can be a reference product for a proposed biosimilar
product or a proposed interchangeable product (see section 351(i)(4) of
the PHS Act). However, a biological product that was first approved in
an NDA under section 505 of the FD&C Act and deemed ``licensed'' under
section 351(a) of the PHS Act on March 23, 2020, will not have been
``first licensed under subsection (a)'' for purposes of section
351(k)(7) of the PHS Act. Thus, such a biological product will not be
eligible for exclusivity under section 351(k)(7)(A) and (B) of the PHS
Act. Moreover, FDA interprets the limitations on eligibility for
reference product exclusivity in section 351(k)(7)(C) of the PHS Act to
apply to any reference product. The guidance also clarifies the
Agency's approach to supplements submitted to an approved NDA for a
biological product before March 23, 2020, that are pending on the
transition date.
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 ``Interpretation of the `Deemed To Be a
License' Provision of the Biologics Price Competition and Innovation
Act of 2009.'' It does not
[[Page 63898]]
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.
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
collection of information in 21 CFR part 312 has been approved under
OMB control number 0910-0014; the collection of information in 21 CFR
part 314 has been approved under OMB control number 0910-0001; the
collection of information in 21 CFR part 601 has been approved under
OMB control number 0910-0338; and the collection of information for
applications submitted under section 351(k) of the PHS Act has been
approved under OMB control number 0910-0719; the collection of
information in FDA's guidance for industry entitled ``Formal Meetings
Between the FDA and Biosimilar Biological Product Sponsors or
Applicants'' has been approved under OMB control number 0910-0802; and
the collection of information in FDA's guidance for industry entitled
``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products'' has been approved under OMB control number 0910-0429.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either 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. 2018-26854 Filed 12-11-18; 8:45 am]
BILLING CODE 4164-01-P