Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability, 8885-8886 [2012-3549]

Download as PDF 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adventitious agent safety, process controls, and specifications) for the product to be adequately reviewed.2 This draft guidance describes important factors for consideration when assessing whether therapeutic protein products are highly similar, including: • Expression System •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Properties • Impurities • Reference Product and Reference Standards • Finished Drug Product • Stability This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on quality considerations in demonstrating biosimilarity to a reference protein product.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 The Paperwork Reduction Act This draft guidance describes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995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 In particular, the draft guidance refers to information collections related to the submission of a 351(k) application.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 In addition, this draft guidance references other information collections that are already approved by OMB and are not expected to change as a result of the draft guidance.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 8886 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 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: sroberts on DSK5SPTVN1PROD with NOTICES I. Background 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 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 (42 U.S.C. 262(k)) for biological products demonstrated to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This draft guidance describes FDA’s current interpretation of certain statutory requirements added by the BPCI Act and includes questions and answers (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. FDA intends to update this guidance to include additional Q&As as appropriate and intends to post information by Q&A number on FDA’s Web site regarding the publication date of draft guidance Q&As for comment, the comment period, and the publication date of final guidance Q&As. VerDate Mar<15>2010 17:09 Feb 14, 2012 Jkt 226001 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 this topic. 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 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. 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 (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 NDA, which is covered under 21 CFR part 312 and approved under OMB control number 0910–0014; (2) an NDA, 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. The draft guidance also discusses the retention of reserve samples of the PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 biological products used in comparative clinical pharmacokinetic and/or pharmacodynamic studies intended to support a proposed 351(k) application. Such reserve samples are samples of products or other physical objects exempt under 5 CFR 1320.3(h)(2), and thus not considered ‘‘information’’ as that term is defined under the PRA. 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. 2012–3549 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–2012–N–0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) Detroit District Office, in co-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA’s clinical trial requirements is designed to aid the clinical research professional’s understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRB, and research sponsors. Date and Time: The public workshop will be held on May 9 and 10, 2012, from 8 a.m. to 5 p.m. SUMMARY: E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Pages 8885-8886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3549]


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

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.

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

SUMMARY: 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 
self-addressed 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.

[[Page 8886]]


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 ``Biosimilars: Questions and Answers Regarding Implementation 
of the Biologics Price Competition and Innovation Act of 2009.'' This 
draft 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 (42 U.S.C. 262(k)) for biological products demonstrated to 
be biosimilar to, or interchangeable with, an FDA-licensed biological 
reference product. This draft guidance describes FDA's current 
interpretation of certain statutory requirements added by the BPCI Act 
and includes questions and answers (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.
    FDA intends to update this guidance to include additional Q&As as 
appropriate and intends to post information by Q&A number on FDA's Web 
site regarding the publication date of draft guidance Q&As for comment, 
the comment period, and the publication date of final guidance Q&As.
    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 this topic. 
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 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.

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 (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 NDA, 
which is covered under 21 CFR part 312 and approved under OMB control 
number 0910-0014; (2) an NDA, 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.
    The draft guidance also discusses the retention of reserve samples 
of the biological products used in comparative clinical pharmacokinetic 
and/or pharmacodynamic studies intended to support a proposed 351(k) 
application. Such reserve samples are samples of products or other 
physical objects exempt under 5 CFR 1320.3(h)(2), and thus not 
considered ``information'' as that term is defined under the PRA.

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. 2012-3549 Filed 2-14-12; 8:45 am]
BILLING CODE 4160-01-P
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