80_FR_24342 80 FR 24259 - Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability

80 FR 24259 - Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 83 (April 30, 2015)

Page Range24259-24260
FR Document2015-10064

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' This guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance finalizes several questions and answers (Q&As) from the draft guidance entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009'' issued February 15, 2012.

Federal Register, Volume 80 Issue 83 (Thursday, April 30, 2015) 
[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24259-24260]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0611]


Biosimilars: Questions and Answers Regarding Implementation of 
the Biologics Price Competition and Innovation Act of 2009; Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Biosimilars: 
Questions and Answers Regarding Implementation of the Biologics Price 
Competition and Innovation Act of 2009.'' This guidance is intended to 
provide answers to common questions from sponsors interested in 
developing proposed biosimilar products, biologics license application 
(BLA) holders, and other interested parties regarding FDA's 
interpretation of the Biologics Price Competition and Innovation Act of 
2009 (BPCI Act). This guidance finalizes several questions and answers 
(Q&As) from the draft guidance entitled ``Biosimilars: Questions and 
Answers Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009'' issued February 15, 2012.

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

ADDRESSES: 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; or Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Suite 200N, Rockville, MD 20852-1448. 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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-
796-1042; 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 guidance for industry 
entitled ``Biosimilars: Questions and Answers Regarding Implementation 
of the

[[Page 24260]]

Biologics Price Competition and Innovation Act of 2009.'' This guidance 
provides answers to common questions from sponsors interested in 
developing proposed biosimilar products, BLA holders, and other 
interested parties regarding FDA's interpretation of the BPCI Act.
    The BPCI Act, enacted as part of the Patient Protection and 
Affordable Care Act (Pub. L. 111-148) on March 23, 2010, created an 
abbreviated licensure pathway under section 351(k) of the Public Health 
Service Act (PHS Act) (42 U.S.C. 262(k)) for biological products 
demonstrated to be biosimilar to, or interchangeable with, an FDA-
licensed reference product. This guidance describes FDA's current 
interpretation of certain statutory requirements added by the BPCI Act 
and includes Q&As in the following categories:
     Biosimilarity or Interchangeability
     Provisions Related to Requirement to Submit a BLA for a 
``Biological Product''
     Exclusivity

The Q&A format is intended to promote transparency and facilitate 
development programs for proposed biosimilar products by addressing 
questions that may arise in the early stages of development. In 
addition, these Q&As respond to questions the Agency has received from 
prospective BLA and new drug application (NDA) applicants regarding the 
appropriate statutory authority under which certain products will be 
regulated.
    In the Federal Register of February 15, 2012 (77 FR 8885), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``Biosimilars: Questions and Answers Regarding Implementation 
of the Biologics Price Competition and Innovation Act of 2009.'' 
Although interested parties can comment on any guidance at any time, to 
ensure that the Agency considered comments on the draft guidance before 
beginning work on the final version of the guidance, FDA requested that 
interested parties submit comments by April 16, 2012. FDA's 
consideration of these comments, among other things, is reflected in a 
revised draft guidance and this final guidance. This guidance describes 
the status of the draft guidance Q&As provided in Revision 1 of the 
draft guidance entitled ``Biosimilars: Additional Questions and Answers 
Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009,'' and the status of the final guidance Q&As 
that are included in this guidance. FDA intends to update these 
guidances to include additional Q&As as appropriate.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on ``Biosimilars: Questions and Answers 
Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009.'' It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

    This guidance refers to information collection provisions that 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 
submission of an investigational new drug application is covered under 
21 CFR part 312 and approved under OMB control number 0910-0014. The 
submission of an NDA is covered under 21 CFR 314.50 and approved under 
OMB control number 0910-0001. The submission of a BLA under section 
351(a) of the PHS Act is covered under part 601 (21 CFR part 601) and 
approved under OMB control number 0910-0338. The submission of a BLA 
under section 351(k) of the PHS Act is covered under part 601 and 
approved under OMB control number 0910-0719. In the Federal Register of 
April 1, 2013 (78 FR 19492), FDA published a notice announcing the 
availability of a draft guidance for industry entitled ``Formal 
Meetings Between the FDA and Biosimilar Biological Product Sponsors or 
Applicants.'' The notice contained an analysis of the information 
collection burden resulting from the draft guidance, and will be 
submitted to OMB for approval before issuance of the final guidance.

IV. Electronic Access

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

    Dated: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10064 Filed 4-29-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices 24259 respect to structure, function, animal will be posted to the docket at http:// availability of a guidance for industry toxicity, human pharmacokinetics (PK) www.regulations.gov. entitled ‘‘Biosimilars: Questions and and pharmacodynamics (PD), clinical Answers Regarding Implementation of III. The Paperwork Reduction Act of immunogenicity, and clinical safety and the Biologics Price Competition and 1995 effectiveness; Innovation Act of 2009.’’ This guidance • The totality-of-the-evidence This guidance describes information is intended to provide answers to approach that FDA will use to review collection provisions that are subject to common questions from sponsors applications for biosimilar products, review by the Office of Management and interested in developing proposed consistent with a longstanding Agency Budget (OMB) under the Paperwork biosimilar products, biologics license approach to evaluation of scientific Reduction Act of 1995 (the PRA) (44 application (BLA) holders, and other evidence; and U.S.C. 3501–3520). This guidance interested parties regarding FDA’s • General scientific principles in references information collections that interpretation of the Biologics Price conducting comparative structural are already approved by OMB and are Competition and Innovation Act of 2009 analyses, functional assays, animal not expected to change as a result of the (BPCI Act). This guidance finalizes testing, human PK and PD studies, guidance. This includes information several questions and answers (Q&As) clinical immunogenicity assessment, collections related to the submission of: from the draft guidance entitled and comparative clinical trials (1) An investigational new drug ‘‘Biosimilars: Questions and Answers (including clinical study design issues). application, which is covered under 21 Regarding Implementation of the In the Federal Register of February CFR part 312 and approved under OMB Biologics Price Competition and 15, 2012 (77 FR 8883), FDA announced Control No. 0910–0014; (2) a new drug Innovation Act of 2009’’ issued the availability of the draft guidance of application, which is covered under 21 February 15, 2012. the same title dated February 2012. FDA CFR 314.50 and approved under OMB DATES: Submit either electronic or received a number of comments on the control number 0910–0001; (3) a written comments on Agency guidances draft guidance. In response to these biologics license application under at any time. comments, FDA provides further section 351(a) of the PHS Act, which is ADDRESSES: Submit written requests for clarification of the scientific covered under 21 CFR part 601 and single copies of this guidance to the considerations applicable to the conduct approved under OMB control number Division of Drug Information, Center for of comparative structural analysis, 0910–0338; and (4) a biologics license Drug Evaluation and Research, Food functional assays, animal studies, and application under section 351(k) of the and Drug Administration, 10001 New clinical testing. The final guidance also PHS Act, which is covered under 21 Hampshire Ave., Hillandale Building, provides additional information on CFR part 601 and approved under OMB 4th Floor, Silver Spring, MD 20993; or clinical trial design and selection of control number 0910–0719. Office of Communication, Outreach and study endpoint and population. It also IV. Electronic Access Development (HFM–40), Center for explains FDA’s current thinking on Persons with access to the Internet Biologics Evaluation and Research when a comparative clinical trial may may obtain the document at either (CBER), Food and Drug Administration, not be needed. In addition, editorial http://www.fda.gov/Drugs/Guidance 1401 Rockville Pike, Suite 200N, changes were made to improve clarity. ComplianceRegulatoryInformation/ Rockville, MD 20852–1448. Send one The guidance announced in this notice Guidances/default.htm, http:// self-addressed adhesive label to assist finalizes and replaces the draft guidance www.fda.gov/BiologicsBloodVaccines/ that office in processing your requests. dated February 2012. GuidanceComplianceRegulatory See the SUPPLEMENTARY INFORMATION This guidance is being issued Information/default.htm, or http:// section for electronic access to the consistent with FDA’s good guidance www.regulations.gov. guidance document. practices regulation (21 CFR 10.115). Submit electronic comments on the The guidance represents the Agency’s Dated: April 24, 2015. guidance to http://www.regulations.gov. current thinking on scientific Peter Lurie, Submit written comments to the considerations in demonstrating Associate Commissioner for Public Health Division of Dockets Management (HFA– biosimilarity to a reference product. It Strategy and Analysis. 305), Food and Drug Administration, does not create or confer any rights for [FR Doc. 2015–10062 Filed 4–29–15; 8:45 am] 5630 Fishers Lane, Rm. 1061, Rockville, or on any person and does not operate BILLING CODE 4164–01–P MD 20852. to bind FDA or the public. An FOR FURTHER INFORMATION CONTACT: alternative approach may be used if Sandra Benton, Center for Drug such approach satisfies the DEPARTMENT OF HEALTH AND Evaluation and Research, Food and requirements of the applicable statutes HUMAN SERVICES Drug Administration, 10903 New and regulations. Hampshire Ave., Bldg. 51, Rm. 6340, Food and Drug Administration Silver Spring, MD 20993–0002, 301– II. Comments [Docket No. FDA–2011–D–0611] 796–1042; or Stephen Ripley, Center for Interested persons may submit either Biologics Evaluation and Research, electronic comments regarding this Biosimilars: Questions and Answers Food and Drug Administration, 10903 document to http://www.regulations.gov Regarding Implementation of the New Hampshire Ave., Bldg. 71, Rm. or written comments to the Division of Biologics Price Competition and 7301, Silver Spring, MD 20993–0002, Innovation Act of 2009; Guidance for mstockstill on DSK4VPTVN1PROD with NOTICES Dockets Management (see ADDRESSES). It 240–402–7911. is only necessary to send one set of Industry; Availability SUPPLEMENTARY INFORMATION: comments. Identify comments with the AGENCY: Food and Drug Administration, docket number found in brackets in the I. Background HHS. heading of this document. Received ACTION: Notice. FDA is announcing the availability of comments may be seen in the Division a guidance for industry entitled of Dockets Management between 9 a.m. SUMMARY: The Food and Drug ‘‘Biosimilars: Questions and Answers and 4 p.m., Monday through Friday, and Administration (FDA) is announcing the Regarding Implementation of the VerDate Sep<11>2014 17:01 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\30APN1.SGM 30APN1

24260 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices Biologics Price Competition and This guidance is being issued IV. Electronic Access Innovation Act of 2009.’’ This guidance consistent with FDA’s good guidance Persons with access to the Internet provides answers to common questions practices regulation (21 CFR 10.115). may obtain the document at http:// from sponsors interested in developing The guidance represents the Agency’s www.fda.gov/Drugs/Guidance proposed biosimilar products, BLA current thinking on ‘‘Biosimilars: ComplianceRegulatoryInformation/ holders, and other interested parties Questions and Answers Regarding Guidances/default.htm, http:// regarding FDA’s interpretation of the Implementation of the Biologics Price www.fda.gov/BiologicsBloodVaccines/ BPCI Act. Competition and Innovation Act of GuidanceComplianceRegulatory The BPCI Act, enacted as part of the 2009.’’ It does not create or confer any Information/default.htm, or http:// Patient Protection and Affordable Care rights for or on any person and does not www.regulations.gov. Act (Pub. L. 111–148) on March 23, operate to bind FDA or the public. An 2010, created an abbreviated licensure Dated: April 24, 2015. alternative approach may be used if pathway under section 351(k) of the such approach satisfies the Peter Lurie, Public Health Service Act (PHS Act) (42 requirements of the applicable statutes Associate Commissioner for Public Health U.S.C. 262(k)) for biological products and regulations. Strategy and Analysis. demonstrated to be biosimilar to, or [FR Doc. 2015–10064 Filed 4–29–15; 8:45 am] interchangeable with, an FDA-licensed II. Comments BILLING CODE 4164–01–P reference product. This guidance Interested persons may submit either describes FDA’s current interpretation electronic comments regarding this of certain statutory requirements added DEPARTMENT OF HEALTH AND document to http://www.regulations.gov HUMAN SERVICES by the BPCI Act and includes Q&As in or written comments to the Division of the following categories: Dockets Management (see ADDRESSES). It Food and Drug Administration • Biosimilarity or Interchangeability is only necessary to send one set of • Provisions Related to Requirement [Docket No. FDA–2015–N–1305] comments. Identify comments with the to Submit a BLA for a ‘‘Biological docket number found in brackets in the Product’’ Multicriteria-Based Ranking Model for heading of this document. Received • Exclusivity Risk Management of Animal Drug comments may be seen in the Division Residues in Milk and Milk Products; The Q&A format is intended to promote of Dockets Management between 9 a.m. transparency and facilitate development Availability and 4 p.m., Monday through Friday, and programs for proposed biosimilar will be posted to the docket at http:// AGENCY: Food and Drug Administration, products by addressing questions that www.regulations.gov. HHS. may arise in the early stages of development. In addition, these Q&As III. The Paperwork Reduction Act of ACTION: Notice. respond to questions the Agency has 1995 SUMMARY: The Food and Drug received from prospective BLA and new Administration (FDA or ‘‘we’’) is drug application (NDA) applicants This guidance refers to information collection provisions that are subject to announcing the availability of a risk regarding the appropriate statutory assessment entitled ‘‘Multicriteria-Based authority under which certain products review by the Office of Management and Budget (OMB) under the Paperwork Ranking Model for Risk Management of will be regulated. Animal Drug Residues in Milk and Milk In the Federal Register of February Reduction Act (PRA) of 1995 (44 U.S.C. 3501–3520). The submission of an Products.’’ The risk assessment is a tool 15, 2012 (77 FR 8885), FDA published to assist with reevaluating which animal a notice announcing the availability of investigational new drug application is covered under 21 CFR part 312 and drug residues should be included in a draft guidance entitled ‘‘Biosimilars: milk testing programs. We undertook Questions and Answers Regarding approved under OMB control number this project in response to a request Implementation of the Biologics Price 0910–0014. The submission of an NDA from the National Conference on Competition and Innovation Act of is covered under 21 CFR 314.50 and Interstate Milk Shipments (NCIMS). 2009.’’ Although interested parties can approved under OMB control number 0910–0001. The submission of a BLA DATES: Submit either electronic or comment on any guidance at any time, under section 351(a) of the PHS Act is written comments on the risk to ensure that the Agency considered covered under part 601 (21 CFR part assessment by July 29, 2015. comments on the draft guidance before beginning work on the final version of 601) and approved under OMB control ADDRESSES: Submit electronic the guidance, FDA requested that number 0910–0338. The submission of comments to http://www.regulations. interested parties submit comments by a BLA under section 351(k) of the PHS gov. Submit written comments on the April 16, 2012. FDA’s consideration of Act is covered under part 601 and risk assessment to the Division of these comments, among other things, is approved under OMB control number Dockets Management (HFA–305), Food reflected in a revised draft guidance and 0910–0719. In the Federal Register of and Drug Administration, 5630 Fishers this final guidance. This guidance April 1, 2013 (78 FR 19492), FDA Lane, Rm. 1061, Rockville, MD 20852. describes the status of the draft published a notice announcing the FOR FURTHER INFORMATION CONTACT: Jane guidance Q&As provided in Revision 1 availability of a draft guidance for Van Doren, Center for Food Safety and of the draft guidance entitled industry entitled ‘‘Formal Meetings Applied Nutrition (HFS–005), Food and Between the FDA and Biosimilar Drug Administration, 5100 Paint Branch mstockstill on DSK4VPTVN1PROD with NOTICES ‘‘Biosimilars: Additional Questions and Answers Regarding Implementation of Biological Product Sponsors or Pkwy., College Park, MD 20740, 240– the Biologics Price Competition and Applicants.’’ The notice contained an 402–2927. Innovation Act of 2009,’’ and the status analysis of the information collection SUPPLEMENTARY INFORMATION: of the final guidance Q&As that are burden resulting from the draft included in this guidance. FDA intends guidance, and will be submitted to OMB I. Background to update these guidances to include for approval before issuance of the final The NCIMS is a voluntary coalition additional Q&As as appropriate. guidance. that includes representatives from VerDate Sep<11>2014 17:01 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\30APN1.SGM 30APN1


Document Created: 2018-02-21 10:15:13
Document Modified: 2018-02-21 10:15:13
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.
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- 796-1042; 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.
FR Citation80 FR 24259 
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