82 FR 44425 - Statistical Approaches To Evaluate Analytical Similarity; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 183 (September 22, 2017)

Page Range		44425-44426
FR Document		2017-20263

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Statistical Approaches to Evaluate Analytical Similarity.'' This draft guidance, when finalized, will provide advice on the evaluation of analytical similarity to sponsors interested in developing biosimilar products. Specifically, this draft guidance describes the type of information a sponsor of a proposed biosimilar product should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan for the proposed biosimilar, and the statistical approaches recommended for evaluating analytical similarity.

Federal Register, Volume 82 Issue 183 (Friday, September 22, 2017)

[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44425-44426]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-20263]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5525]

Statistical Approaches To Evaluate Analytical Similarity; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled
``Statistical Approaches to Evaluate Analytical Similarity.'' This
draft guidance, when finalized, will provide advice on the evaluation
of analytical similarity to sponsors interested in developing
biosimilar products. Specifically, this draft guidance describes the
type of information a sponsor of a proposed biosimilar product should
obtain about the structural/physicochemical and functional attributes
of the reference product, how that information is used in the
development of an analytical similarity assessment plan for the
proposed biosimilar, and the statistical approaches recommended for
evaluating analytical similarity.

DATES: Submit either electronic or written comments on the draft
guidance by November 21, 2017 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 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-2017-D-5525 for ``Statistical Approaches to Evaluate Analytical
Similarity; 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 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.thefederalregister.org/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 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

[[Page 44426]]

INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Scott N. Goldie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-2055, or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD
20993-0002, 800-835-4709 or 240-402-8010.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Statistical Approaches to Evaluate Analytical Similarity.''
This draft guidance, when finalized, will provide advice on the
evaluation of analytical similarity to sponsors interested in
developing biosimilar products for licensure under section 351(k) of
the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). This
evaluation is performed to support a demonstration that the proposed
biosimilar is highly similar to a reference product licensed under
section 351(a) of the PHS Act.
Specifically, this draft guidance, when finalized, will describe
the type of information that the sponsor of a proposed biosimilar
product should obtain about the structural/physicochemical and
functional attributes of the reference product, how that information is
used in the development of an analytical similarity assessment plan for
the proposed biosimilar, and the statistical approaches recommended for
evaluating analytical similarity.
The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) created an abbreviated licensure pathway under section 351(k) of
the PHS Act for biological products shown to be biosimilar to or
interchangeable with a U.S.-licensed biological reference product (see
sections 7001 through 7003 of Pub. L. 111-148). As described in section
351(k)(2)(A)(i)(I)(aa) of the PHS Act, an application for a proposed
biosimilar product must include information demonstrating biosimilarity
based on data derived from, among other things, ``analytical studies
that demonstrate that the biological product is highly similar to the
reference product notwithstanding minor differences in clinically
inactive components.''
This draft guidance is one in a series of guidance documents
intended to implement the BPCI Act. It serves as a companion document
to the guidance for industry entitled ``Quality Considerations in
Demonstrating Biosimilarity of a Therapeutic Protein Product to a
Reference Product'' (April 30, 2015, 80 FR 24257). The Quality
Considerations guidance describes the Agency's recommendations to
sponsors on the scientific and technical information, including the
analytical studies to support a demonstration that a proposed
biosimilar is highly similar to the U.S.-licensed reference product,
for the chemistry, manufacturing, and controls section of a marketing
application for a proposed biosimilar product.
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 statistical
approaches to evaluating analytical similarity. 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 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). This
includes information collections related to: (1) The submission of an
investigational new drug application, which is covered under 21 CFR
part 312 and approved under OMB control number 0910-0014; (2) the
submission of a new drug application, which is covered under 21 CFR
314.50 and approved under OMB control number 0910-0001; (3) the
submission of a biologics license application under section 351(k) of
the PHS Act, which is covered under 21 CFR part 601 and approved under
OMB control number 0910-0719; and (4) meetings between FDA and
applicants or sponsors of a biologics license application under section
351(k) of the PHS Act, which is approved under OMB control number 0910-
0802.

III. Electronic Access

Persons with access to the internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20263 Filed 9-21-17; 8:45 am]
BILLING CODE 4164-01-P

44426 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices

INFORMATION section for electronic companion document to the guidance Dated: September 15, 2017.
access to the draft guidance document. for industry entitled ‘‘Quality Anna K. Abram,
FOR FURTHER INFORMATION CONTACT: Considerations in Demonstrating Deputy Commissioner for Policy, Planning,
Scott N. Goldie, Center for Drug Biosimilarity of a Therapeutic Protein Legislation, and Analysis.
Evaluation and Research, Food and Product to a Reference Product’’ (April [FR Doc. 2017–20263 Filed 9–21–17; 8:45 am]
Drug Administration, 10903 New 30, 2015, 80 FR 24257). The Quality BILLING CODE 4164–01–P
Hampshire Ave., Silver Spring, MD Considerations guidance describes the
20993, 301–796–2055, or the Office of Agency’s recommendations to sponsors
Communication, Outreach, and on the scientific and technical DEPARTMENT OF HEALTH AND
Development, Center for Biologics information, including the analytical HUMAN SERVICES
Evaluation and Research, 10903 New studies to support a demonstration that
Hampshire Ave., Silver Spring, MD a proposed biosimilar is highly similar Food and Drug Administration
20993–0002, 800–835–4709 or 240– to the U.S.-licensed reference product, [Docket No. FDA–2017–N–0001]
402–8010. for the chemistry, manufacturing, and
SUPPLEMENTARY INFORMATION: controls section of a marketing Vaccines and Related Biological
application for a proposed biosimilar Products Advisory Committee; Notice
I. Background product. of Meeting
FDA is announcing the availability of This draft guidance is being issued
AGENCY: Food and Drug Administration,
a draft guidance for industry entitled consistent with FDA’s good guidance
HHS.
‘‘Statistical Approaches to Evaluate practices regulation (21 CFR 10.115).
Analytical Similarity.’’ This draft The draft guidance, when finalized, will ACTION: Notice.
guidance, when finalized, will provide represent the current thinking of FDA
SUMMARY: The Food and Drug
advice on the evaluation of analytical on statistical approaches to evaluating
Administration (FDA) announces a
similarity to sponsors interested in analytical similarity. It does not
forthcoming public advisory committee
developing biosimilar products for establish any rights for any person and
meeting of the Vaccines and Related
licensure under section 351(k) of the is not binding on FDA or the public.
Biological Products Advisory
Public Health Service Act (PHS Act) (42 You can use an alternative approach if
Committee (VRBPAC). The general
U.S.C. 262(k)). This evaluation is it satisfies the requirements of the
function of the committee is to provide
performed to support a demonstration applicable statutes and regulations. This
advice and recommendations to the
that the proposed biosimilar is highly guidance is not subject to Executive
Agency on FDA’s regulatory issues. The
similar to a reference product licensed Order 12866.
meeting will be open to the public.
under section 351(a) of the PHS Act. II. Paperwork Reduction Act of 1995 DATES: The meeting will be held on
Specifically, this draft guidance,
when finalized, will describe the type of This draft guidance refers to November 7, 2017, from 8:30 a.m. to 5
information that the sponsor of a previously approved collections of p.m.
proposed biosimilar product should information found in FDA regulations. ADDRESSES: FDA White Oak Campus,
obtain about the structural/ These collections of information are 10903 New Hampshire Ave., Bldg. 31
physicochemical and functional subject to review by the Office of Conference Center, the Great Room (Rm.
attributes of the reference product, how Management and Budget (OMB) under 1503), Silver Spring, MD 20993–0002.
that information is used in the the Paperwork Reduction Act of 1995 For those unable to attend in person, the
development of an analytical similarity (44 U.S.C. 3501–3520). This includes meeting will also be webcast and will be
assessment plan for the proposed information collections related to: (1) available at the following link: https://
biosimilar, and the statistical The submission of an investigational collaboration.fda.gov/cbervrbpac2017.
approaches recommended for evaluating new drug application, which is covered Answers to commonly asked questions
analytical similarity. under 21 CFR part 312 and approved including information regarding special
The Biologics Price Competition and under OMB control number 0910–0014; accommodations due to a disability,
Innovation Act of 2009 (BPCI Act) (2) the submission of a new drug visitor parking, and transportation may
created an abbreviated licensure application, which is covered under 21 be accessed at: https://www.fda.gov/
pathway under section 351(k) of the CFR 314.50 and approved under OMB AdvisoryCommittees/AboutAdvisory
PHS Act for biological products shown control number 0910–0001; (3) the Committees/ucm408555.htm.
to be biosimilar to or interchangeable submission of a biologics license FOR FURTHER INFORMATION CONTACT:
with a U.S.-licensed biological reference application under section 351(k) of the Serina Hunter-Thomas, Center for
product (see sections 7001 through 7003 PHS Act, which is covered under 21 Biologics Evaluation and Research,
of Pub. L. 111–148). As described in CFR part 601 and approved under OMB Food and Drug Administration, 10903
section 351(k)(2)(A)(i)(I)(aa) of the PHS control number 0910–0719; and (4) New Hampshire Ave., Bldg. 71, Rm.
Act, an application for a proposed meetings between FDA and applicants 6307C, Silver Spring, MD 20993–0002,
biosimilar product must include or sponsors of a biologics license 240–402–5771, serina.hunter-thomas@
information demonstrating biosimilarity application under section 351(k) of the fda.hhs.gov; or Rosanna Harvey, Center
based on data derived from, among PHS Act, which is approved under OMB for Biologics Evaluation and Research,
other things, ‘‘analytical studies that control number 0910–0802. Food and Drug Administration, 10903
demonstrate that the biological product New Hampshire Ave., Bldg. 71, Rm.
III. Electronic Access
is highly similar to the reference 6336, Silver Spring, MD 20993–0002,
product notwithstanding minor Persons with access to the internet 240–402–8072, rosanna.harvey@
differences in clinically inactive may obtain the draft guidance at either fda.hhs.gov; or FDA Advisory
components.’’ http://www.fda.gov/Drugs/Guidance Committee Information Line, 1–800–
This draft guidance is one in a series ComplianceRegulatoryInformation/ 741–8138 (301–443–0572 in the
of guidance documents intended to Guidances/default.htm or https:// Washington, DC area). A notice in the
implement the BPCI Act. It serves as a www.regulations.gov. Federal Register about last minute

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Document Created: 2017-09-22 01:52:19
Document Modified: 2017-09-22 01:52:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		Submit either electronic or written comments on the draft guidance by November 21, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		Scott N. Goldie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-2055, or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 800-835-4709 or 240-402-8010.
FR Citation		82 FR 44425

82 FR 44425 - Statistical Approaches To Evaluate Analytical Similarity; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 183 (September 22, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration