Considerations in Demonstrating Interchangeability With a Reference Product; Draft Guidance for Industry; Availability, 5579-5580 [2017-01042]
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Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0154]
Considerations in Demonstrating
Interchangeability With a Reference
Product; Draft Guidance for Industry;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announcing the availability of a draft
guidance for industry entitled
‘‘Considerations in Demonstrating
Interchangeability With a Reference
Product.’’ This guidance is intended to
assist sponsors in demonstrating that a
proposed therapeutic protein product
(proposed interchangeable product or
proposed product) is interchangeable
with a reference product for the
purposes of submitting a marketing
application or supplement under the
Public Health Service Act (PHS Act).
This guidance is one in a series of
guidances that FDA has developed to
implement the Biologics Price
Competition and Innovation Act of 2009
(BPCI Act).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 20,
2017.
SUMMARY:
ADDRESSES:
You may submit comments
as follows:
mstockstill on DSK3G9T082PROD with NOTICES
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
VerDate Sep<11>2014
17:41 Jan 17, 2017
Jkt 241001
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2017–D–0154 for ‘‘Considerations in
Demonstrating Interchangeability With a
Reference Product; Draft 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 Division of Dockets
Management 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 Division of Dockets
Management. 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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
5579
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the 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 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 draft guidance document.
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 draft guidance for industry entitled
‘‘Considerations in Demonstrating
Interchangeability With a Reference
Product.’’ This guidance is intended to
assist sponsors in demonstrating that a
proposed therapeutic protein product
(proposed interchangeable product or
proposed product) is interchangeable
with a reference product for the
purposes of submitting a marketing
application or supplement under
section 351(k) of the PHS Act (42 U.S.C.
262(k)). The BPCI Act amends the PHS
Act and other statutes to create an
E:\FR\FM\18JAN1.SGM
18JAN1
mstockstill on DSK3G9T082PROD with NOTICES
5580
Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
abbreviated licensure pathway in
section 351(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 Of 2010 (Affordable Care Act) (Pub.
L. 111–148)).
Section 351(k) of the PHS Act sets
forth the requirements for an
application for a proposed biosimilar
product and an application or a
supplement for a proposed
interchangeable product. Specifically,
section 351(k)(4) provides that upon
review of an application submitted
under section 351(k), or any supplement
to such an application, FDA will
determine the biological product to be
interchangeable with the reference
product if FDA determines that the
information submitted in the
application (or supplement) is sufficient
to show that the biological product is
biosimilar to the reference product and
can be expected to produce the same
clinical result as the reference product
in any given patient; and for a biological
product that is administered more than
once to an individual, the risk in terms
of safety or diminished efficacy of
alternating or switching between use of
the biological product and the reference
product is not greater than the risk of
using the reference product without
such alternation or switch. Section
351(i) of the PHS Act states that the
term interchangeable or
interchangeability, in reference to a
biological product that is shown to meet
the standards described in subsection
351(k)(4), means that the biological
product may be substituted for the
reference product without the
intervention of the health care provider
who prescribed the reference product.
This guidance gives an overview of
important scientific considerations in
demonstrating interchangeability,
including:
• The data and information needed to
support a demonstration of
interchangeability;
• Considerations for the design and
analysis of a switching study or studies
to support a demonstration of
interchangeability;
• Recommendations regarding the use
of U.S.-licensed reference products in a
switching study or studies; and
• Considerations for developing
presentations, container closure
systems, and delivery device constituent
parts for proposed interchangeable
products.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
VerDate Sep<11>2014
17:41 Jan 17, 2017
Jkt 241001
The draft guidance, when finalized, will
represent the current thinking of FDA
on topics sponsors should consider
when seeking to demonstrate that a
proposed therapeutic protein product is
interchangeable with a reference
product. It does not establish any rights
for any person and is not binding on
FDA or the public.
II. Topics for Comment
In addition to comment on the draft
guidance, we also invite general
comments on interchangeability,
including comments on regulation of an
interchangeable product over its
lifecycle, as well as comments on the
following topics:
1. Since the mid-1990s, FDA has
approved manufacturing changes for
biological products based on data from
comparability assessments comparing
the pre-change and post-change product
using comparative analytical, and, when
necessary, animal and/or clinical (e.g.,
pharmacokinetic, immunogenicity)
studies. A demonstration of
comparability between pre- and postchange product supports a
determination that the safety and
efficacy profile remains the same for the
product. With respect to
interchangeable products, are there
considerations in addition to
comparability assessments that FDA
should consider in regulating postapproval manufacturing changes of
interchangeable products? Your
comments should include the scientific
rationale and justification for your
recommendations, as well as
recommendations for processes and
systems (including key logistics) to
implement your recommendations.
2. As explained in the guidance
‘‘Considerations in Demonstrating
Interchangeability With a Reference
Product,’’ FDA expects that sponsors
seeking an interchangeability
determination will submit data and
information to support a showing that
the proposed interchangeable product
can be expected to produce the same
clinical result as the reference product
in all of the reference product’s licensed
conditions of use. How, if at all, should
the Agency consider conditions of use
that are licensed for the reference
product after an interchangeable
product has been licensed? Your
comments should include the scientific
rationale and justification for your
recommendations, as well as
recommendations for processes and
systems (including key logistics) to
implement your recommendations.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
III. 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 under 21 CFR part 312
have been approved under OMB control
number 0910–0014; the collections of
information under 21 CFR part 601 have
been approved under OMB control
number 0910–0338; and the collections
of information under section 351(k) of
the PHS Act have been approved under
OMB control number 0910–0719.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at 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: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–01042 Filed 1–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–2469]
Determination That SYMMETREL
(Amantadine Hydrochloride), Syrup, 50
Milligrams/5 Milliliters, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that SYMMETREL
(amantadine hydrochloride), Syrup, 50
milligrams/5 milliliters (50 mg/5 mL),
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to SYMMETREL,
and it will allow FDA to continue to
approve ANDAs that reference
SYMMETREL if all other legal and
regulatory requirements are met.
SUMMARY:
E:\FR\FM\18JAN1.SGM
18JAN1
Agencies
[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5579-5580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01042]
[[Page 5579]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-0154]
Considerations in Demonstrating Interchangeability With a
Reference Product; Draft 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 draft guidance for industry entitled
``Considerations in Demonstrating Interchangeability With a Reference
Product.'' This guidance is intended to assist sponsors in
demonstrating that a proposed therapeutic protein product (proposed
interchangeable product or proposed product) is interchangeable with a
reference product for the purposes of submitting a marketing
application or supplement under the Public Health Service Act (PHS
Act). This guidance is one in a series of guidances that FDA has
developed to implement the Biologics Price Competition and Innovation
Act of 2009 (BPCI Act).
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 20, 2017.
ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2017-D-0154 for ``Considerations in Demonstrating
Interchangeability With a Reference Product; Draft 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 Division of
Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the 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 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 draft guidance document.
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 draft guidance for industry
entitled ``Considerations in Demonstrating Interchangeability With a
Reference Product.'' This guidance is intended to assist sponsors in
demonstrating that a proposed therapeutic protein product (proposed
interchangeable product or proposed product) is interchangeable with a
reference product for the purposes of submitting a marketing
application or supplement under section 351(k) of the PHS Act (42
U.S.C. 262(k)). The BPCI Act amends the PHS Act and other statutes to
create an
[[Page 5580]]
abbreviated licensure pathway in section 351(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 Of 2010 (Affordable Care
Act) (Pub. L. 111-148)).
Section 351(k) of the PHS Act sets forth the requirements for an
application for a proposed biosimilar product and an application or a
supplement for a proposed interchangeable product. Specifically,
section 351(k)(4) provides that upon review of an application submitted
under section 351(k), or any supplement to such an application, FDA
will determine the biological product to be interchangeable with the
reference product if FDA determines that the information submitted in
the application (or supplement) is sufficient to show that the
biological product is biosimilar to the reference product and can be
expected to produce the same clinical result as the reference product
in any given patient; and for a biological product that is administered
more than once to an individual, the risk in terms of safety or
diminished efficacy of alternating or switching between use of the
biological product and the reference product is not greater than the
risk of using the reference product without such alternation or switch.
Section 351(i) of the PHS Act states that the term interchangeable or
interchangeability, in reference to a biological product that is shown
to meet the standards described in subsection 351(k)(4), means that the
biological product may be substituted for the reference product without
the intervention of the health care provider who prescribed the
reference product.
This guidance gives an overview of important scientific
considerations in demonstrating interchangeability, including:
The data and information needed to support a demonstration
of interchangeability;
Considerations for the design and analysis of a switching
study or studies to support a demonstration of interchangeability;
Recommendations regarding the use of U.S.-licensed
reference products in a switching study or studies; and
Considerations for developing presentations, container
closure systems, and delivery device constituent parts for proposed
interchangeable products.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on topics
sponsors should consider when seeking to demonstrate that a proposed
therapeutic protein product is interchangeable with a reference
product. It does not establish any rights for any person and is not
binding on FDA or the public.
II. Topics for Comment
In addition to comment on the draft guidance, we also invite
general comments on interchangeability, including comments on
regulation of an interchangeable product over its lifecycle, as well as
comments on the following topics:
1. Since the mid-1990s, FDA has approved manufacturing changes for
biological products based on data from comparability assessments
comparing the pre-change and post-change product using comparative
analytical, and, when necessary, animal and/or clinical (e.g.,
pharmacokinetic, immunogenicity) studies. A demonstration of
comparability between pre- and post-change product supports a
determination that the safety and efficacy profile remains the same for
the product. With respect to interchangeable products, are there
considerations in addition to comparability assessments that FDA should
consider in regulating post-approval manufacturing changes of
interchangeable products? Your comments should include the scientific
rationale and justification for your recommendations, as well as
recommendations for processes and systems (including key logistics) to
implement your recommendations.
2. As explained in the guidance ``Considerations in Demonstrating
Interchangeability With a Reference Product,'' FDA expects that
sponsors seeking an interchangeability determination will submit data
and information to support a showing that the proposed interchangeable
product can be expected to produce the same clinical result as the
reference product in all of the reference product's licensed conditions
of use. How, if at all, should the Agency consider conditions of use
that are licensed for the reference product after an interchangeable
product has been licensed? Your comments should include the scientific
rationale and justification for your recommendations, as well as
recommendations for processes and systems (including key logistics) to
implement your recommendations.
III. 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 under 21 CFR part 312 have been approved
under OMB control number 0910-0014; the collections of information
under 21 CFR part 601 have been approved under OMB control number 0910-
0338; and the collections of information under section 351(k) of the
PHS Act have been approved under OMB control number 0910-0719.
IV. Electronic Access
Persons with access to the Internet may obtain the draft 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: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01042 Filed 1-17-17; 8:45 am]
BILLING CODE 4164-01-P