Labeling for Biosimilar Products; Draft Guidance for Industry; Availability, 19194-19195 [2016-07611]
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19194
Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/RegulatoryInformation/
Guidances/, https://www.regulations.gov,
or https://www.fda.gov/medicalcounter
measures.
Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07478 Filed 4–1–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0643]
Labeling for Biosimilar Products; Draft
Guidance for Industry; Availability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announcing the availability of a draft
guidance for industry entitled ‘‘Labeling
for Biosimilar Products.’’ This draft
guidance is intended to assist applicants
in developing draft prescription drug
labeling for proposed biosimilar
products. The recommendations for
prescription drug labeling in this
guidance pertain only to the prescribing
information (commonly referred to as
the package insert). This draft guidance
provides an overview of FDA’s
recommendations for labeling for
biosimilar products licensed under the
Public Health Service Act (PHS 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considers your comment on this draft
guidance before it begins work on the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on the draft guidance by June 3, 2016.
ADDRESSES: You may submit comments
as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
19:03 Apr 01, 2016
Jkt 238001
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–
2016–D–0643 for ‘‘Labeling for
Biosimilar Products; 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
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
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 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, 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
‘‘Labeling for Biosimilar Products.’’ The
Biologics Price Competition and
Innovation Act of 2009 (BCPI Act),
enacted as part of the Patient Protection
and Affordable Care Act (Affordable
Care Act) (Pub. L. 111–148) on March
23, 2010, created an abbreviated
E:\FR\FM\04APN1.SGM
04APN1
Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
licensure pathway for biological
products demonstrated to be biosimilar
to or interchangeable with a reference
product. Section 351(k) of the PHS Act
(42 U.S.C. 262(k)), added by the BPCI
Act, sets forth the requirements for an
application for a proposed biosimilar
product and an application or
supplement for a proposed
interchangeable product. Under section
351(k) of the PHS Act, a proposed
biological product that is demonstrated
to be biosimilar to a reference product
can rely on certain existing scientific
knowledge about the safety, purity, and
potency of the reference product to
support licensure, and this is reflected
in the approach to biosimilar product
labeling.
In this draft guidance, FDA outlines
its recommendations for biosimilar
product labeling. A demonstration of
biosimilarity means, among other
things, that FDA has determined that
there are no clinically meaningful
differences between the proposed
product and the reference product in
terms of safety, purity and potency.
Accordingly, biosimilar applicants
should incorporate relevant data and
information from the reference product
labeling, with appropriate productspecific modifications as described in
the draft guidance.
We invite comment on the draft
guidance, including whether patient
labeling (e.g., Patient Information,
Medication Guide, and Instructions for
Use) should include a biosimilarity
statement similar to the statement
described in section IV.C.1 of the draft
guidance.
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 labeling for biosimilar products. 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.
II. The 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 (PRA) of
1995 (44 U.S.C. 3501–3520). The
collections of information under 21 CFR
part 601 for the submission of a
biologics license application under
section 351(k) of the PHS Act have been
VerDate Sep<11>2014
19:03 Apr 01, 2016
Jkt 238001
19195
approved under OMB control number
0910–0719; the collections of
information under 21 CFR 201.57 for the
submission of labeling have been
approved under OMB control number
0910–0572; the collections of
information under 21 CFR part 600 for
the submission of adverse experience
reporting for licensed biological
products and general records have been
approved under OMB control number
0910–0308; and the collections of
information under 21 CFR part 600 for
the submission of MedWatch reporting
forms (FDA Form 3500 and FDA Form
3500A) have been approved under OMB
control number 0910–0291.
supplements to these applications. This
guidance also applies to comparability
protocols submitted in investigational
new animal drug (INAD), generic
investigational new animal drug
(JINAD), and veterinary master file
(VMF) submissions that are referenced
in applications. FDA is providing this
guidance in response to requests from
those interested in using comparability
protocols.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
III. 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.
Electronic Submissions
Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07611 Filed 4–1–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0938 (formerly
FDA–2003–D–0034 and 2003D–0061)]
Comparability Protocols—Chemistry,
Manufacturing, and Controls
Information for New Animal Drugs;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
Written/Paper Submissions
The Food and Drug
Administration (FDA) is announcing the
availability of a final guidance for
industry (#156) entitled ‘‘Comparability
Protocols—Chemistry, Manufacturing,
and Controls Information for New
Animal Drugs.’’ This document
provides recommendations to
applicants on preparing and using
comparability protocols for
postapproval changes in chemistry,
manufacturing, and controls (CMC)
information. It is intended to provide
recommendations to industry regarding
comparability protocols that would be
submitted in new animal drug
applications (NADAs), abbreviated new
animal drug applications (ANADAs), or
SUMMARY:
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
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’’).
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–
2016–D–0938 for ‘‘Comparability
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19194-19195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07611]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-0643]
Labeling for Biosimilar Products; 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 ``Labeling
for Biosimilar Products.'' This draft guidance is intended to assist
applicants in developing draft prescription drug labeling for proposed
biosimilar products. The recommendations for prescription drug labeling
in this guidance pertain only to the prescribing information (commonly
referred to as the package insert). This draft guidance provides an
overview of FDA's recommendations for labeling for biosimilar products
licensed under the Public Health Service Act (PHS 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 June 3, 2016.
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-2016-D-0643 for ``Labeling for Biosimilar Products; 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 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, 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 ``Labeling for Biosimilar Products.'' The Biologics Price
Competition and Innovation Act of 2009 (BCPI Act), enacted as part of
the Patient Protection and Affordable Care Act (Affordable Care Act)
(Pub. L. 111-148) on March 23, 2010, created an abbreviated
[[Page 19195]]
licensure pathway for biological products demonstrated to be biosimilar
to or interchangeable with a reference product. Section 351(k) of the
PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, sets forth the
requirements for an application for a proposed biosimilar product and
an application or supplement for a proposed interchangeable product.
Under section 351(k) of the PHS Act, a proposed biological product that
is demonstrated to be biosimilar to a reference product can rely on
certain existing scientific knowledge about the safety, purity, and
potency of the reference product to support licensure, and this is
reflected in the approach to biosimilar product labeling.
In this draft guidance, FDA outlines its recommendations for
biosimilar product labeling. A demonstration of biosimilarity means,
among other things, that FDA has determined that there are no
clinically meaningful differences between the proposed product and the
reference product in terms of safety, purity and potency. Accordingly,
biosimilar applicants should incorporate relevant data and information
from the reference product labeling, with appropriate product-specific
modifications as described in the draft guidance.
We invite comment on the draft guidance, including whether patient
labeling (e.g., Patient Information, Medication Guide, and Instructions
for Use) should include a biosimilarity statement similar to the
statement described in section IV.C.1 of the draft guidance.
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 labeling for
biosimilar products. 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.
II. The 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 (PRA) of 1995 (44 U.S.C. 3501-3520).
The collections of information under 21 CFR part 601 for the submission
of a biologics license application under section 351(k) of the PHS Act
have been approved under OMB control number 0910-0719; the collections
of information under 21 CFR 201.57 for the submission of labeling have
been approved under OMB control number 0910-0572; the collections of
information under 21 CFR part 600 for the submission of adverse
experience reporting for licensed biological products and general
records have been approved under OMB control number 0910-0308; and the
collections of information under 21 CFR part 600 for the submission of
MedWatch reporting forms (FDA Form 3500 and FDA Form 3500A) have been
approved under OMB control number 0910-0291.
III. 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: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07611 Filed 4-1-16; 8:45 am]
BILLING CODE 4164-01-P