
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44425-44426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Statistical Approaches To Evaluate Analytical Similarity; Draft 
Guidance for Industry; Availability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.

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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the availability of a draft guidance for industry entitled 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draft guidance, when finalized, will provide advice on the evaluation 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 Specifically, this draft guidance describes the 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DATES: Submit either electronic or written comments on the draft 
guidance by November 21, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.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 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


