Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; Availability, 24257-24258 [2015-10063]

Download as PDF Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices 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: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0602] Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.’’ This guidance is intended to provide sponsors with an overview of analytical factors that are relevant to assessing whether a proposed product and the reference product are highly similar for the purpose of submitting a marketing application through an abbreviated licensure pathway. This guidance finalizes the draft guidance issued in February 2012.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, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002 or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and 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. Submit electronic comments on the guidance to https://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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:01 Apr 29, 2015 Jkt 235001 I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.’’ This guidance is intended to provide sponsors with an overview of analytical factors that are relevant to assessing whether a proposed product and the reference product are highly similar for the purpose of submitting a marketing application through the abbreviated licensure pathway under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). 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, 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 FDA ‘‘determines that the information submitted in the application . . . is sufficient to show that the biological product . . . is biosimilar to the reference product . . .’’ and the 351(k) applicant (or other appropriate person) consents to an inspection of the facility that is the subject of the application (i.e., a facility in which the proposed biological product is manufactured, processed, packed, or held).1 All product applications should contain a complete and thorough chemistry, manufacturing, and controls section that provides the necessary and appropriate information, including, but not limited to, characterization, adventitious agent safety, process controls, and specifications, for the product to be adequately reviewed.2 1 Section 7002(a)(2) of the Affordable Care Act, adding section 351(k)(3) of the PHS Act (citing section 351(a)(2)(C) of the PHS Act). 2 For CMC requirements for submission of a marketing application, applicants should consult current regulations, the guidance for industry for the ‘‘Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 24257 This guidance describes important factors for consideration when assessing whether a proposed product and the reference product are highly similar, including: • Expression System • Manufacturing Process • Assessment of Physiochemical Properties • Functional Activities • Receptor Binding and Immunochemical Properties • Impurities • Reference Product and Reference Standards • Finished Drug Product • Stability 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’’ dated February 2012. FDA received a number of comments on the draft guidance. In response to these comments, this guidance provides further clarification on general principles on topics including, but not limited to, the use of comparative analytical data to provide the foundation for a biosimilar development program, the timing of submission of analytical similarity data, the appropriate number of lots needed, and the type of bridging data needed when sponsors use a non-U.S.-licensed comparator product in certain studies. The guidance provides additional clarification on the factors for consideration in assessing whether a proposed product is highly similar to the reference product. This guidance finalizes the draft guidance issued in February 2012. 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 quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. 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 https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In-Vivo Use,’’ and other applicable FDA guidance documents. E:\FR\FM\30APN1.SGM 30APN1 24258 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices 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 https:// www.regulations.gov. III. The Paperwork Reduction Act of 1995 Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https://www.fda. gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm, or https:// www.regulations.gov. mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 17:01 Apr 29, 2015 Jkt 235001 [Docket No. FDA–2011–D–0605] Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry; Availability Food and Drug Administration, HHS. IV. Electronic Access [FR Doc. 2015–10063 Filed 4–29–15; 8:45 am] Food and Drug Administration AGENCY: 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. Dated: April 24, 2015. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.’’ This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway. This guidance gives an overview of FDA’s approach to determining biosimilarity. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the 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 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. Submit electronic comments on the guidance to https://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. SUMMARY: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.’’ This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is ‘‘biosimilar’’ 1 to a reference product for the purpose of submitting a marketing application through the abbreviated licensure pathway under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The Biologics Price Competition and Innovation Act of 2009 (BPCI Act), enacted as part of the Affordable Care Act (Pub. L. 111–148) on March 23, 2010, 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 FDA ‘‘determines that the information submitted in the application . . . is sufficient to show that the biological product is biosimilar to the reference product. . . .’’ and the 351(k) applicant (or other appropriate person) consents to an inspection of the facility that is the subject of the application (i.e., a facility in which the proposed biological product is manufactured, processed, packed, or held).2 The guidance gives an overview of FDA’s approach to determining biosimilarity. FDA intends to consider the totality of the evidence submitted in a 351(k) application and is recommending that sponsors use a stepwise approach in their development of biosimilar products. The guidance discusses important scientific considerations in demonstrating biosimilarity, including: • A stepwise approach to demonstrating biosimilarity, which can include a comparison of the proposed product and the reference product with 1 In section 7002(b)(3) of the Patient Protection and Affordable Care Act (Affordable Care Act), Pub. L. 111–148, ‘‘biosimilar’’ or ‘‘biosimilarity’’ means ‘‘that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components,’’ and that ‘‘there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.’’ 2 Section 7002(a)(2) of the Affordable Care Act, adding section 351(k)(3) of the PHS Act (citing section 351(a)(2)(C) of the PHS Act). E:\FR\FM\30APN1.SGM 30APN1

Agencies

[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24257-24258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10063]

[[Page 24257]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0602]

Guidance for Industry on Quality Considerations in Demonstrating
Biosimilarity of a Therapeutic Protein Product to a Reference Product;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Quality
Considerations in Demonstrating Biosimilarity of a Therapeutic Protein
Product to a Reference Product.'' This guidance is intended to provide
sponsors with an overview of analytical factors that are relevant to
assessing whether a proposed product and the reference product are
highly similar for the purpose of submitting a marketing application
through an abbreviated licensure pathway. This guidance finalizes the
draft guidance issued in February 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, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and 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.
Submit electronic comments on the guidance to https://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 ``Quality Considerations in Demonstrating Biosimilarity of a
Therapeutic Protein Product to a Reference Product.'' This guidance is
intended to provide sponsors with an overview of analytical factors
that are relevant to assessing whether a proposed product and the
reference product are highly similar for the purpose of submitting a
marketing application through the abbreviated licensure pathway under
section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C.
262(k)). 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, 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 FDA ``determines that the information submitted in the
application . . . is sufficient to show that the biological product . .
. is biosimilar to the reference product . . .'' and the 351(k)
applicant (or other appropriate person) consents to an inspection of
the facility that is the subject of the application (i.e., a facility
in which the proposed biological product is manufactured, processed,
packed, or held).\1\
---------------------------------------------------------------------------

\1\ Section 7002(a)(2) of the Affordable Care Act, adding
section 351(k)(3) of the PHS Act (citing section 351(a)(2)(C) of the
PHS Act).
---------------------------------------------------------------------------

All product applications should contain a complete and thorough
chemistry, manufacturing, and controls section that provides the
necessary and appropriate information, including, but not limited to,
characterization, adventitious agent safety, process controls, and
specifications, for the product to be adequately reviewed.\2\ This
guidance describes important factors for consideration when assessing
whether a proposed product and the reference product are highly
similar, including:
---------------------------------------------------------------------------

\2\ For CMC requirements for submission of a marketing
application, applicants should consult current regulations, the
guidance for industry for the ``Submission of Chemistry,
Manufacturing, and Controls Information for a Therapeutic
Recombinant DNA-Derived Product or a Monoclonal Antibody Product for
In-Vivo Use,'' and other applicable FDA guidance documents.
---------------------------------------------------------------------------

Expression System
Manufacturing Process
Assessment of Physiochemical Properties
Functional Activities
Receptor Binding and Immunochemical Properties
Impurities
Reference Product and Reference Standards
Finished Drug Product
Stability
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'' dated February 2012. FDA received a number of comments on the
draft guidance. In response to these comments, this guidance provides
further clarification on general principles on topics including, but
not limited to, the use of comparative analytical data to provide the
foundation for a biosimilar development program, the timing of
submission of analytical similarity data, the appropriate number of
lots needed, and the type of bridging data needed when sponsors use a
non-U.S.-licensed comparator product in certain studies. The guidance
provides additional clarification on the factors for consideration in
assessing whether a proposed product is highly similar to the reference
product. This guidance finalizes the draft guidance issued in February
2012.
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 quality considerations in demonstrating
biosimilarity of a therapeutic protein product to a reference product.
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 https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It

[[Page 24258]]

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 https://www.regulations.gov.

III. The 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.

IV. Electronic Access

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

Dated: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10063 Filed 4-29-15; 8:45 am]
BILLING CODE 4164-01-P

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