81_FR_96260 81 FR 96010 - Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability

81 FR 96010 - Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 250 (December 29, 2016)

Page Range96010-96011
FR Document2016-31511

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.'' This guidance is to assist the pharmaceutical industry and other investigators engaged in biosimilar product development in determining the clinical pharmacology data necessary for evaluation of a proposed biosimilar product. This guidance finalizes the draft guidance with the same name issued in May 2014. This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Federal Register, Volume 81 Issue 250 (Thursday, December 29, 2016) 
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96010-96011]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31511]



[[Page 96010]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0234]


Clinical Pharmacology Data To Support a Demonstration of 
Biosimilarity to a Reference Product; 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 guidance for industry entitled ``Clinical 
Pharmacology Data to Support a Demonstration of Biosimilarity to a 
Reference Product.'' This guidance is to assist the pharmaceutical 
industry and other investigators engaged in biosimilar product 
development in determining the clinical pharmacology data necessary for 
evaluation of a proposed biosimilar product. This guidance finalizes 
the draft guidance with the same name issued in May 2014. This guidance 
is one in a series of guidances that FDA is developing to implement the 
Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2014-D-0234 for ``Clinical Pharmacology Data To Support a 
Demonstration of Biosimilarity to a Reference Product; Guidance for 
Industry; Availability.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://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 http://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: http://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 http://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 this 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 (CBER), 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 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-
796-2500; 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 guidance for industry 
entitled ``Clinical Pharmacology Data to Support a Demonstration of 
Biosimilarity to a Reference Product.'' This guidance is intended to 
assist the pharmaceutical industry and other investigators engaged in 
biosimilar product development with the design and use of clinical 
pharmacology data necessary for evaluation of a proposed biosimilar 
product. This guidance provides recommendations on how clinical 
pharmacology studies that assess the presence or absence of clinically 
meaningful differences between the proposed biosimilar product and the 
U.S.-licensed reference product should be conducted and analyzed to 
address questions arising during biosimilar product development.

[[Page 96011]]

    Clinical pharmacology studies are part of a stepwise approach for 
developing the data and information needed to support a demonstration 
of biosimilarity. These studies can reduce the residual uncertainty in 
assessing the biosimilarity between a proposed biosimilar product and 
reference product and inform the design of subsequent clinical trials 
to assess clinically meaningful differences. This guidance is intended 
to assist sponsors in designing such studies in support of applications 
submitted under section 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)), as added by the BPCI Act.\1\ In particular, this 
guidance discusses certain critical considerations for using clinical 
pharmacology testing to support biosimilarity, approaches for 
developing the appropriate clinical pharmacology database to support a 
demonstration of biosimilarity, and the utility of modeling and 
simulation for designing and analyzing clinical trials. Scientific 
principles described in the guidance may also be informative for the 
development of certain biological products under section 505(b)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)).
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    \1\ The BPCI Act was enacted as part of the Patient Protection 
and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
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    On May 14, 2014, FDA issued a notice announcing the availability of 
a draft guidance with the same name as the current guidance to solicit 
comments from the public (79 FR 27622). After carefully reviewing 
received comments and in light of increased regulatory experience and 
the evolution of the science in biosimilar product development and 
evaluation, FDA has finalized that guidance with certain changes. These 
changes are for clarity, however, and are not substantive.
    This guidance is one in a series that FDA is developing to 
implement the BPCI Act and is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on conducting clinical pharmacology studies 
in support of proposed 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

    The guidance refers to previously approved collections of 
information that 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 collection of information submitted under section 351(k) 
applications for biosimilars is approved under OMB control number 0910-
0719. The collection of information submitted under 21 CFR part 312 is 
approved under OMB control number 0910-0014.

III. Electronic Access

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

    Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31511 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P

96010 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). default.htm. Docket: For access to the docket to Food and Drug Administration Written/Paper Submissions read background documents or the [Docket No. FDA–2014–D–0234] Submit written/paper submissions as electronic and written/paper comments follows: received, go to http:// Clinical Pharmacology Data To • Mail/Hand delivery/Courier (for www.regulations.gov and insert the Support a Demonstration of written/paper submissions): Division of docket number, found in brackets in the Biosimilarity to a Reference Product; Dockets Management (HFA–305), Food heading of this document, into the Guidance for Industry; Availability and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets AGENCY: Food and Drug Administration, • For written/paper comments Management, 5630 Fishers Lane, Rm. HHS. 1061, Rockville, MD 20852. submitted to the Division of Dockets ACTION: Notice of availability. Management, FDA will post your Submit written requests for single SUMMARY: The Food and Drug comment, as well as any attachments, copies of this guidance to the Division Administration (FDA or Agency) is except for information submitted, of Drug Information, Center for Drug announcing the availability of a marked and identified, as confidential, Evaluation and Research, Food and guidance for industry entitled ‘‘Clinical if submitted as detailed in Drug Administration, 10001 New Pharmacology Data to Support a ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, Demonstration of Biosimilarity to a Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– Reference Product.’’ This guidance is to must include the Docket No. FDA– 0002; or to the Office of assist the pharmaceutical industry and 2014–D–0234 for ‘‘Clinical Communication, Outreach and other investigators engaged in biosimilar Pharmacology Data To Support a Development, Center for Biologics product development in determining Demonstration of Biosimilarity to a Evaluation and Research (CBER), Food the clinical pharmacology data Reference Product; Guidance for and Drug Administration, 10903 New necessary for evaluation of a proposed Industry; Availability.’’ Received Hampshire Ave., Bldg. 71, Rm. 3128, biosimilar product. This guidance comments will be placed in the docket Silver Spring, MD 20993–0002. Send finalizes the draft guidance with the and, except for those submitted as one self-addressed adhesive label to same name issued in May 2014. This ‘‘Confidential Submissions,’’ publicly assist that office in processing your guidance is one in a series of guidances viewable at http://www.regulations.gov requests. See the SUPPLEMENTARY that FDA is developing to implement or at the Division of Dockets INFORMATION section for electronic the Biologics Price Competition and Management between 9 a.m. and 4 p.m., access to the guidance document. Innovation Act of 2009 (BPCI Act). Monday through Friday. FOR FURTHER INFORMATION CONTACT: DATES: Submit either electronic or • Confidential Submissions—To Sandra Benton, Center for Drug written comments on Agency guidances submit a comment with confidential Evaluation and Research, Food and at any time. information that you do not wish to be Drug Administration, 10903 New ADDRESSES: You may submit comments made publicly available, submit your Hampshire Ave., Bldg. 51, Rm. 6340, as follows: comments only as a written/paper Silver Spring, MD 20993–0002, 301– submission. You should submit two 796–2500; or Stephen Ripley, Center for Electronic Submissions copies total. One copy will include the Biologics Evaluation and Research, Submit electronic comments in the information you claim to be confidential Food and Drug Administration, 10903 following way: with a heading or cover note that states New Hampshire Ave., Bldg. 71, Rm. • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS 7301, Silver Spring, MD 20993–0002, www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The 240–402–7911. instructions for submitting comments. Agency will review this copy, including SUPPLEMENTARY INFORMATION: Comments submitted electronically, the claimed confidential information, in its consideration of comments. The I. Background including attachments, to http:// www.regulations.gov will be posted to second copy, which will have the FDA is announcing the availability of the docket unchanged. Because your claimed confidential information a guidance for industry entitled comment will be made public, you are redacted/blacked out, will be available ‘‘Clinical Pharmacology Data to Support solely responsible for ensuring that your for public viewing and posted on http:// a Demonstration of Biosimilarity to a comment does not include any www.regulations.gov. Submit both Reference Product.’’ This guidance is confidential information that you or a copies to the Division of Dockets intended to assist the pharmaceutical third party may not wish to be posted, Management. If you do not wish your industry and other investigators engaged such as medical information, your or name and contact information to be in biosimilar product development with anyone else’s Social Security number, or made publicly available, you can the design and use of clinical confidential business information, such provide this information on the cover pharmacology data necessary for as a manufacturing process. Please note sheet and not in the body of your evaluation of a proposed biosimilar that if you include your name, contact comments and you must identify this product. This guidance provides information, or other information that information as ‘‘confidential.’’ Any recommendations on how clinical asabaliauskas on DSK3SPTVN1PROD with NOTICES identifies you in the body of your information marked as ‘‘confidential’’ pharmacology studies that assess the comments, that information will be will not be disclosed except in presence or absence of clinically posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other meaningful differences between the • If you want to submit a comment applicable disclosure law. For more proposed biosimilar product and the with confidential information that you information about FDA’s posting of U.S.-licensed reference product should do not wish to be made available to the comments to public dockets, see 80 FR be conducted and analyzed to address public, submit the comment as a 56469, September 18, 2015, or access questions arising during biosimilar written/paper submission and in the the information at: http://www.fda.gov/ product development. VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1

Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96011 Clinical pharmacology studies are the Paperwork Reduction Act of 1995 DATES: Although you can comment on part of a stepwise approach for (44 U.S.C. 3501–3520). The collection of any guidance at any time (see 21 CFR developing the data and information information submitted under section 10.115(g)(5)), to ensure that the Agency needed to support a demonstration of 351(k) applications for biosimilars is considers your comment on this draft biosimilarity. These studies can reduce approved under OMB control number guidance before it begins work on the the residual uncertainty in assessing the 0910–0719. The collection of final version of the guidance, submit biosimilarity between a proposed information submitted under 21 CFR either electronic or written comments biosimilar product and reference part 312 is approved under OMB control on the draft guidance by February 27, product and inform the design of number 0910–0014. 2017. Submit either electronic or subsequent clinical trials to assess written comments concerning the III. Electronic Access collection of information proposed in clinically meaningful differences. This guidance is intended to assist sponsors Persons with access to the Internet the draft guidance by February 27, 2017. in designing such studies in support of may obtain the guidance at either http:// ADDRESSES: You may submit comments applications submitted under section www.fda.gov/Drugs/Guidance as follows: 351(k) of the Public Health Service Act ComplianceRegulatoryInformation/ Guidances/default.htm, http:// Electronic Submissions (42 U.S.C. 262(k)), as added by the BPCI Act.1 In particular, this guidance www.fda.gov/BiologicsBloodVaccines/ Submit electronic comments in the discusses certain critical considerations GuidanceComplianceRegulatory following way: for using clinical pharmacology testing Information/default.htm, or http:// • Federal eRulemaking Portal: to support biosimilarity, approaches for www.regulations.gov. https://www.regulations.gov. Follow the developing the appropriate clinical instructions for submitting comments. Dated: December 22, 2016. pharmacology database to support a Comments submitted electronically, Leslie Kux, demonstration of biosimilarity, and the including attachments, to https:// Associate Commissioner for Policy. www.regulations.gov will be posted to utility of modeling and simulation for [FR Doc. 2016–31511 Filed 12–28–16; 8:45 am] the docket unchanged. Because your designing and analyzing clinical trials. Scientific principles described in the BILLING CODE 4164–01–P comment will be made public, you are guidance may also be informative for solely responsible for ensuring that your the development of certain biological comment does not include any DEPARTMENT OF HEALTH AND confidential information that you or a products under section 505(b)(2) of the HUMAN SERVICES Federal Food, Drug, and Cosmetic Act third party may not wish to be posted, (21 U.S.C. 355(b)(2)). such as medical information, your or Food and Drug Administration On May 14, 2014, FDA issued a notice anyone else’s Social Security number, or announcing the availability of a draft [Docket No. FDA–2016–D–4318] confidential business information, such guidance with the same name as the as a manufacturing process. Please note current guidance to solicit comments Compounding and Repackaging of that if you include your name, contact from the public (79 FR 27622). After Radiopharmaceuticals by State- information, or other information that carefully reviewing received comments Licensed Nuclear Pharmacies and identifies you in the body of your and in light of increased regulatory Federal Facilities; Draft Guidance for comments, that information will be experience and the evolution of the Industry; Availability posted on https://www.regulations.gov. science in biosimilar product • If you want to submit a comment AGENCY: Food and Drug Administration, with confidential information that you development and evaluation, FDA has HHS. finalized that guidance with certain do not wish to be made available to the changes. These changes are for clarity, ACTION: Notice. public, submit the comment as a however, and are not substantive. written/paper submission and in the SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper This guidance is one in a series that Administration (FDA or Agency) is FDA is developing to implement the Submissions’’ and ‘‘Instructions’’). announcing the availability of a draft BPCI Act and is being issued consistent guidance for industry entitled Written/Paper Submissions with FDA’s good guidance practices ‘‘Compounding and Repackaging of regulation (21 CFR 10.115). The Submit written/paper submissions as Radiopharmaceuticals by State-Licensed follows: guidance represents the current thinking Nuclear Pharmacies and Federal • Mail/Hand delivery/Courier (for of FDA on conducting clinical Facilities.’’ This guidance sets forth written/paper submissions): Division of pharmacology studies in support of FDA’s policy regarding compounding Dockets Management (HFA–305), Food proposed biosimilar products. It does and repackaging of and Drug Administration, 5630 Fishers not establish any rights for any person radiopharmaceuticals for human use by Lane, Rm. 1061, Rockville, MD 20852. and is not binding on FDA or the public. State-licensed nuclear pharmacies and • For written/paper comments You can use an alternative approach if Federal facilities that are not registered submitted to the Division of Dockets it satisfies the requirements of the as outsourcing facilities. Because such Management, FDA will post your applicable statutes and regulations. radiopharmaceuticals are not eligible for comment, as well as any attachments, II. The Paperwork Reduction Act of exemptions from provisions of the except for information submitted, Federal Food, Drug, and Cosmetic Act marked and identified, as confidential, asabaliauskas on DSK3SPTVN1PROD with NOTICES 1995 The guidance refers to previously (the FD&C Act) related to the production if submitted as detailed in approved collections of information that of drugs, FDA is issuing this guidance ‘‘Instructions.’’ to describe the conditions under which Instructions: All submissions received are subject to review by the Office of it does not intend to take action for must include the Docket No. FDA– Management and Budget (OMB) under violations of certain provisions of the 2016–D–4318 for ‘‘Compounding and 1 The BPCI Act was enacted as part of the Patient FD&C Act when a State-licensed nuclear Repackaging of Radiopharmaceuticals Protection and Affordable Care Act (Pub. L. 111– pharmacy or Federal facility compounds by State-Licensed Nuclear Pharmacies 148) on March 23, 2010. or repackages radiopharmaceuticals. and Federal Facilities.’’ Received VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1


Document Created: 2016-12-29 01:58:14
Document Modified: 2016-12-29 01:58:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactSandra 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- 796-2500; 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.
FR Citation81 FR 96010 
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