Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; Availability, 8884-8885 [2012-3550]

Download as PDF 8884 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices default.htm, https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. 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. sroberts on DSK5SPTVN1PROD with NOTICES 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. Dated: February 9, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. III. The Paperwork Reduction Act This draft guidance describes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520). In particular, the draft guidance refers to information collections related to the submission of 351(k) application. In accordance with the PRA, FDA is soliciting public comment, in a separate document published elsewhere in this issue of the Federal Register (see ‘‘Agency Information Collection Activities: Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications’’) on the information collection associated with the submission of a 351(k) application. FDA will also seek OMB approval for this information collection. In addition, this draft guidance references other information collections that are already approved by OMB and are not expected to change as a result of the draft guidance. This includes information collections 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, which is covered under 21 CFR part 601 and approved under OMB control number 0910–0338; and (4) labeling, which is covered under 21 CFR 201.57 and approved under OMB control number 0910–0572. Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; Availability IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ VerDate Mar<15>2010 17:09 Feb 14, 2012 Jkt 226001 [FR Doc. 2012–3552 Filed 2–14–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0602] AGENCY: Food and Drug Administration, HHS. ACTION: I. Background Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product.’’ This draft guidance is intended to provide sponsors with an overview of analytical factors to consider when assessing biosimilarity between a proposed protein product and a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway. This draft guidance provides an overview of FDA’s approach to quality considerations in determining biosimilarity. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 16, 2012. ADDRESSES: 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, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002, or Office of Communication, Outreach, and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one selfaddressed adhesive label to assist that office in processing your requests. See SUMMARY: PO 00000 Frm 00084 Fmt 4703 the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft 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 (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: Sfmt 4703 FDA is announcing the availability of a draft guidance for industry entitled ‘‘Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product.’’ This draft guidance is intended to provide sponsors with an overview of analytical factors to consider when assessing biosimilarity between a proposed protein product and 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)). Although the 351(k) pathway applies generally to biological products, this draft guidance focuses on therapeutic protein products. The Biologics Price Competition and Innovation Act of 2009, enacted as part of the Patient Protection and Affordable Care Act (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 E:\FR\FM\15FEN1.SGM 15FEN1 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices manufactured, processed, packed, or held).1 All product applications should contain a complete and thorough Chemistry, Manufacturing, and Controls (CMC) section that provides the necessary and appropriate information (e.g., characterization, adventitious agent safety, process controls, and specifications) for the product to be adequately reviewed.2 This draft guidance describes important factors for consideration when assessing whether therapeutic protein products 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 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 Agency’s current thinking on quality considerations in demonstrating biosimilarity to a reference protein 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. sroberts on DSK5SPTVN1PROD with NOTICES II. The Paperwork Reduction Act This draft guidance describes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520). In particular, the draft guidance refers to information collections related to the submission of a 351(k) application. In accordance with the PRA, FDA is soliciting public comment, in a separate document published elsewhere in this issue of the Federal Register (see ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications’’) on the information collection associated with the submission of a 351(k) application. FDA will also seek OMB approval for this information collection. In addition, this draft guidance references other information collections that are already approved by OMB and are not expected to change as a result of the draft guidance. This includes information collections 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; and (3) a biologics license application which is covered under 21 CFR part 601 and approved under OMB control number 0910–0338. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: February 9, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–3550 Filed 2–14–12; 8:45 am] BILLING CODE 4160–01–P 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 on Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In-vivo Use (issued jointly by CBER and CDER, August 1996), and other applicable FDA guidance documents. VerDate Mar<15>2010 18:46 Feb 14, 2012 Jkt 226001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 8885 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0611] Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.’’ This draft 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). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 16, 2012. Submit either electronic or written comments on the proposed collection of information by April 16, 2012. ADDRESSES: 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, 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, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one selfaddressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft 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. SUMMARY: E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Pages 8884-8885]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3550]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Quality 
Considerations in Demonstrating Biosimilarity to a Reference Protein 
Product.'' This draft guidance is intended to provide sponsors with an 
overview of analytical factors to consider when assessing biosimilarity 
between a proposed protein product and a reference product for the 
purpose of submitting a marketing application through an abbreviated 
licensure pathway. This draft guidance provides an overview of FDA's 
approach to quality considerations in determining biosimilarity.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 16, 2012.

ADDRESSES: 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or 
Office of Communication, Outreach, and Development (HFM-40), Center for 
Biologics Evaluation and Research, 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 draft guidance document.
    Submit electronic comments on the draft 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 (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Quality Considerations in Demonstrating Biosimilarity to a 
Reference Protein Product.'' This draft guidance is intended to provide 
sponsors with an overview of analytical factors to consider when 
assessing biosimilarity between a proposed protein product and 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)). Although the 
351(k) pathway applies generally to biological products, this draft 
guidance focuses on therapeutic protein products.
    The Biologics Price Competition and Innovation Act of 2009, enacted 
as part of the Patient Protection and Affordable Care Act (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

[[Page 8885]]

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 (CMC) section that provides the 
necessary and appropriate information (e.g., characterization, 
adventitious agent safety, process controls, and specifications) for 
the product to be adequately reviewed.\2\ This draft guidance describes 
important factors for consideration when assessing whether therapeutic 
protein products 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 on Chemistry, 
Manufacturing, and Controls Information for a Therapeutic 
Recombinant DNA-Derived Product or a Monoclonal Antibody Product for 
In-vivo Use (issued jointly by CBER and CDER, August 1996), 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

    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 Agency's current thinking on quality 
considerations in demonstrating biosimilarity to a reference protein 
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. The Paperwork Reduction Act

    This draft guidance describes information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). In particular, the draft guidance refers to information 
collections related to the submission of a 351(k) application. In 
accordance with the PRA, FDA is soliciting public comment, in a 
separate document published elsewhere in this issue of the Federal 
Register (see ``Agency Information Collection Activities; Proposed 
Collection; Comment Request; General Licensing Provisions; Section 
351(k) Biosimilar Applications'') on the information collection 
associated with the submission of a 351(k) application. FDA will also 
seek OMB approval for this information collection.
    In addition, this draft guidance references other information 
collections that are already approved by OMB and are not expected to 
change as a result of the draft guidance. This includes information 
collections 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; and (3) a biologics license application which is covered under 21 
CFR part 601 and approved under OMB control number 0910-0338.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

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: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3550 Filed 2-14-12; 8:45 am]
BILLING CODE 4160-01-P
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