Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Draft Guidance for Industry; Availability, 23569-23571 [2019-10667]
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23569
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Mary B. Jones,
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[FR Doc. 2019–10701 Filed 5–21–19; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–2102]
jbell on DSK3GLQ082PROD with NOTICES
Development of Therapeutic Protein
Biosimilars: Comparative Analytical
Assessment and Other Quality-Related
Considerations; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
17:29 May 21, 2019
Jkt 247001
Rounded
number of
responses per
respondent
Number of
respondents
Instrument
5,265,682
635,049
54
53
4,075
1.39
103.46
135,185.19
26.00
1.00
Average burden hours per
response
.025 hours (1.5 minutes) .............
.00028 hours (1 second) .............
.017 hours (1 minute) ..................
.00028 hours (1 second) .............
.050 hours (3 minutes) ................
announcing the availability of a draft
guidance for industry entitled
‘‘Development of Therapeutic Protein
Biosimilars: Comparative Analytical
Assessment and Other Quality-Related
Considerations.’’ This draft guidance
describes the Agency’s
recommendations on the design and
evaluation of comparative analytical
studies intended to support a
demonstration that a proposed
therapeutic protein product is
biosimilar to a reference product
licensed under the Public Health
Service Act (PHS Act). Additionally,
this draft guidance is intended to
provide recommendations to sponsors
on the scientific and technical
information for the chemistry,
manufacturing, and controls (CMC)
portion of a marketing application for a
proposed product submitted under the
PHS Act. This draft guidance revises the
guidance entitled ‘‘Quality
Considerations in Demonstrating
Biosimilarity of a Therapeutic Protein
Product to a Reference Product’’ that
was published on April 30, 2015.
DATES: Submit either electronic or
written comments on the draft guidance
PO 00000
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Fmt 4703
Sfmt 4703
Total
182,982.45
18,396.61
124,100.00
0.39
203.75
by July 22, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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
E:\FR\FM\22MYN1.SGM
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Federal Register / Vol. 84, No. 99 / Wednesday, May 22, 2019 / Notices
jbell on DSK3GLQ082PROD with NOTICES
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–
2019–D–2102 for ‘‘Development of
Therapeutic Protein Biosimilars:
Comparative Analytical Assessment and
Other Quality-Related Considerations.’’
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
VerDate Sep<11>2014
17:29 May 21, 2019
Jkt 247001
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
‘‘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 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. 75, Rm. 6522,
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
‘‘Development of Therapeutic Protein
Biosimilars: Comparative Analytical
Assessment and Other Quality-Related
Considerations.’’ This draft guidance
describes the Agency’s
recommendations on the design and
evaluation of comparative analytical
studies intended to support a
demonstration that a proposed
therapeutic protein product is
biosimilar to a reference product
licensed under section 351(a) of the PHS
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Act (42 U.S.C. 262(a)). Additionally, this
draft guidance is intended to provide
recommendations to sponsors on of the
scientific and technical information for
the CMC portion of a marketing
application for a proposed product
submitted under section 351(k) of the
PHS Act. Although the 351(k) pathway
applies generally to biological products,
this guidance focuses on therapeutic
protein products.
The Biologics Price Competition and
Innovation Act of 2009 was enacted as
part of the Patient Protection and
Affordable Care Act (Pub. L. 111–148)
on March 23, 2010, and created an
abbreviated licensure pathway under
section 351(k) of the PHS Act for
biological products demonstrated to be
biosimilar to, or interchangeable with, a
reference product. Under this
abbreviated licensure pathway, FDA
will license a proposed biological
product submitted under section 351(k)
of the PHS Act if, among other things,
FDA determines that the information
submitted in the application is
sufficient to show that the biological
product is biosimilar to the reference
product.
In the Federal Register of February
15, 2012 (77 FR 8884), FDA announced
the availability of the draft guidance
entitled ‘‘Quality Considerations in
Demonstrating Biosimilarity to a
Reference Protein Product.’’ FDA
received a number of comments on the
draft guidance. In response to these
comments, FDA provided further
clarification on the general principles
described through a final guidance
entitled ‘‘Quality Considerations in
Demonstrating Biosimilarity of a
Therapeutic Protein Product to a
Reference Product,’’ which was
announced in the Federal Register of
April 30, 2015 (80 FR 24257).
In the Federal Register of September
22, 2017 (82 FR 44425), FDA announced
the availability of the draft guidance
entitled ‘‘Statistical Approaches to
Evaluate Analytical Similarity.’’ FDA
received a number of comments on the
draft guidance. Comments submitted to
the docket addressed a range of issues
that could impact the cost and
efficiency of biosimilar development,
including the number of reference
product lots the draft guidance would
have recommended that biosimilar
developers sample in their evaluation of
high similarity and the statistical
methods for this evaluation. After
considering the public comments that
FDA received, FDA determined it would
withdraw the draft guidance to give
further consideration to the scientific
and regulatory issues involved. FDA
announced the withdrawal of the draft
E:\FR\FM\22MYN1.SGM
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Federal Register / Vol. 84, No. 99 / Wednesday, May 22, 2019 / Notices
jbell on DSK3GLQ082PROD with NOTICES
guidance on June 21, 2018, with the
intention of issuing future draft
guidance on the evaluation of analytical
data to support a demonstration that a
proposed biosimilar product is highly
similar to a reference product.
This draft guidance revises the
guidance issued on April 30, 2015. FDA
has adjusted the title of this draft
guidance to more clearly communicate
that this draft guidance includes the
Agency’s recommendations on the
design and evaluation of comparative
analytical studies intended to support a
demonstration that a proposed
therapeutic protein product is
biosimilar to a reference product. In
addition to editorial and clarifying edits,
the draft guidance includes a section
that fulfills the Biosimilar User Fee Act
II commitment to publish a revised draft
or final guidance, describing statistical
considerations for the analysis of
analytical similarity data intended to
support a demonstration of ‘‘highly
similar’’ for biosimilar biological
products within 18 months after the
close of the public comment period for
the withdrawn guidance, ‘‘Statistical
Approaches to Evaluate Analytical
Similarity.’’
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 ‘‘Development of Therapeutic
Protein Biosimilars: Comparative
Analytical Assessment and Other
Quality-Related Considerations.’’ 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.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations, which are not
expected to change as a result of the
guidance. 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 related to the
submission of: (1) An investigational
new drug application, which is covered
under 21 CFR part 312 and approved
under OMB control number 0910–0014;
(2) a new drug application, which is
covered under 21 CFR 314.50 and
approved under OMB control number
0910–0001; (3) a biologics license
application (BLA) under section 351(a)
of the PHS Act, which is covered under
VerDate Sep<11>2014
17:29 May 21, 2019
Jkt 247001
part 601 (21 CFR part 601) and
approved under OMB control number
0910–0338; and (4) a BLA under section
351(k), which is covered under part 601
and 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, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: May 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10667 Filed 5–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Changes to the Scholarships
to Disadvantaged Students Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for public comment on
the Scholarships for Disadvantaged
Students program.
AGENCY:
The Scholarships for
Disadvantaged Students (SDS) program
is authorized by the Public Health
Service Act (PHS Act) and administered
by HRSA. The program promotes
diversity among the health professions
and nursing workforce by providing
awards to eligible health professions
and nursing schools for use in awarding
scholarships to students from
disadvantaged backgrounds. This notice
seeks public comment to inform and
guide policy and planning associated
with the SDS program.
DATES: Individuals and organizations
interested in providing information
must submit written comments no later
than 11:59 p.m. Eastern Time on June
21, 2019.
ADDRESSES: Interested parties should
submit their comments to Denise
Sorrell, SDS Project Officer, via email at
SDSProgram@HRSA.gov. Please include
the title of this notice, ‘‘Request for
Comment: SDS Program’’ in the subject
line of the email. Response to this
request is voluntary. Responders are free
to address any or all of the proposals
listed below. This request is for
SUMMARY:
PO 00000
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Sfmt 4703
23571
information and planning purposes only
and should not be construed as a
solicitation or as an obligation on the
part of the federal government. All
submitted comments will be available to
the public in their entirety.
FOR FURTHER INFORMATION CONTACT:
Denise Sorrell, SDS Project Officer,
Division of Health Careers and Financial
Support, Bureau of Health Workforce,
HRSA, 5600 Fishers Lane, Room 15N78,
Rockville, Maryland 20857, phone (301)
443–2909, or email SDSProgram@
HRSA.gov.
SUPPLEMENTARY INFORMATION: HRSA is
considering updating the SDS program
to increase the impact of the program.
The authorizing statute allows the
Secretary of HHS to make grants to
certain health professions and nursing
schools that are carrying out a program
for recruiting and retaining students
from disadvantaged backgrounds,
including students who are members of
racial and ethnic minority groups, to
provide scholarships to eligible students
(PHS Act, Sec. 737(a), (d)(1)). Grantees
provide scholarships to individuals who
meet the following requirements: (1) are
from disadvantaged backgrounds; (2)
have a financial need for a scholarship;
and (3) are enrolled (or accepted for
enrollment) at an eligible health
professions or nursing school as a fulltime student in a program leading to a
degree in a health profession or nursing
(PHS Act, Sec. 737(d)(2)(A–C)). Under
the statute, priority is given to eligible
entities based on the proportion of
graduating students practicing in
primary care settings, the proportion of
underrepresented minority student
enrollees and graduates, and the
proportion of graduates working in
medically underserved communities
(MUCs) (PHS Act, Sec. 737(c)). The PHS
Act requires HRSA to award at least 16
percent of the available funds to schools
of nursing (PHS Act, Sec. 740(a)).
Eligible applicants are public or nonprofit private accredited schools of
allopathic medicine, osteopathic
medicine, dentistry, nursing, pharmacy,
podiatric medicine, optometry,
veterinary medicine, public health,
chiropractic, or allied health; a school
offering a graduate program in
behavioral and mental health practice;
or an entity providing programs for the
training of physician assistants as
determined in Section 737(d)(1)(A) of
the PHS Act. Faith-based and
community-based organizations, tribes,
and tribal organizations are eligible to
apply if all other eligibility
requirements are met. Additionally,
Section 737(d)(2) requires ‘‘a school
must be carrying out a recruitment and
E:\FR\FM\22MYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 99 (Wednesday, May 22, 2019)]
[Notices]
[Pages 23569-23571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10667]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-2102]
Development of Therapeutic Protein Biosimilars: Comparative
Analytical Assessment and Other Quality-Related Considerations; 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
``Development of Therapeutic Protein Biosimilars: Comparative
Analytical Assessment and Other Quality-Related Considerations.'' This
draft guidance describes the Agency's recommendations on the design and
evaluation of comparative analytical studies intended to support a
demonstration that a proposed therapeutic protein product is biosimilar
to a reference product licensed under the Public Health Service Act
(PHS Act). Additionally, this draft guidance is intended to provide
recommendations to sponsors on the scientific and technical information
for the chemistry, manufacturing, and controls (CMC) portion of a
marketing application for a proposed product submitted under the PHS
Act. This draft guidance revises the guidance entitled ``Quality
Considerations in Demonstrating Biosimilarity of a Therapeutic Protein
Product to a Reference Product'' that was published on April 30, 2015.
DATES: Submit either electronic or written comments on the draft
guidance by July 22, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your
[[Page 23570]]
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-2019-D-2102 for ``Development of Therapeutic Protein Biosimilars:
Comparative Analytical Assessment and Other Quality-Related
Considerations.'' 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 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. 75, Rm. 6522, 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 ``Development of Therapeutic Protein Biosimilars: Comparative
Analytical Assessment and Other Quality-Related Considerations.'' This
draft guidance describes the Agency's recommendations on the design and
evaluation of comparative analytical studies intended to support a
demonstration that a proposed therapeutic protein product is biosimilar
to a reference product licensed under section 351(a) of the PHS Act (42
U.S.C. 262(a)). Additionally, this draft guidance is intended to
provide recommendations to sponsors on of the scientific and technical
information for the CMC portion of a marketing application for a
proposed product submitted under section 351(k) of the PHS Act.
Although the 351(k) pathway applies generally to biological products,
this guidance focuses on therapeutic protein products.
The Biologics Price Competition and Innovation Act of 2009 was
enacted as part of the Patient Protection and Affordable Care Act (Pub.
L. 111-148) on March 23, 2010, and created an abbreviated licensure
pathway under section 351(k) of the PHS Act for biological products
demonstrated to be biosimilar to, or interchangeable with, a reference
product. Under this abbreviated licensure pathway, FDA will license a
proposed biological product submitted under section 351(k) of the PHS
Act if, among other things, FDA determines that the information
submitted in the application is sufficient to show that the biological
product is biosimilar to the reference product.
In the Federal Register of February 15, 2012 (77 FR 8884), FDA
announced the availability of the draft guidance entitled ``Quality
Considerations in Demonstrating Biosimilarity to a Reference Protein
Product.'' FDA received a number of comments on the draft guidance. In
response to these comments, FDA provided further clarification on the
general principles described through a final guidance entitled
``Quality Considerations in Demonstrating Biosimilarity of a
Therapeutic Protein Product to a Reference Product,'' which was
announced in the Federal Register of April 30, 2015 (80 FR 24257).
In the Federal Register of September 22, 2017 (82 FR 44425), FDA
announced the availability of the draft guidance entitled ``Statistical
Approaches to Evaluate Analytical Similarity.'' FDA received a number
of comments on the draft guidance. Comments submitted to the docket
addressed a range of issues that could impact the cost and efficiency
of biosimilar development, including the number of reference product
lots the draft guidance would have recommended that biosimilar
developers sample in their evaluation of high similarity and the
statistical methods for this evaluation. After considering the public
comments that FDA received, FDA determined it would withdraw the draft
guidance to give further consideration to the scientific and regulatory
issues involved. FDA announced the withdrawal of the draft
[[Page 23571]]
guidance on June 21, 2018, with the intention of issuing future draft
guidance on the evaluation of analytical data to support a
demonstration that a proposed biosimilar product is highly similar to a
reference product.
This draft guidance revises the guidance issued on April 30, 2015.
FDA has adjusted the title of this draft guidance to more clearly
communicate that this draft guidance includes the Agency's
recommendations on the design and evaluation of comparative analytical
studies intended to support a demonstration that a proposed therapeutic
protein product is biosimilar to a reference product. In addition to
editorial and clarifying edits, the draft guidance includes a section
that fulfills the Biosimilar User Fee Act II commitment to publish a
revised draft or final guidance, describing statistical considerations
for the analysis of analytical similarity data intended to support a
demonstration of ``highly similar'' for biosimilar biological products
within 18 months after the close of the public comment period for the
withdrawn guidance, ``Statistical Approaches to Evaluate Analytical
Similarity.''
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 ``Development
of Therapeutic Protein Biosimilars: Comparative Analytical Assessment
and Other Quality-Related Considerations.'' 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.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations, which are not expected to change
as a result of the guidance. 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 related to the submission of: (1) An
investigational new drug application, which is covered under 21 CFR
part 312 and approved under OMB control number 0910-0014; (2) a new
drug application, which is covered under 21 CFR 314.50 and approved
under OMB control number 0910-0001; (3) a biologics license application
(BLA) under section 351(a) of the PHS Act, which is covered under part
601 (21 CFR part 601) and approved under OMB control number 0910-0338;
and (4) a BLA under section 351(k), which is covered under part 601 and
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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: May 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10667 Filed 5-21-19; 8:45 am]
BILLING CODE 4164-01-P
