
[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Draft Guidance for Industry on Quality Considerations in 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availability of a draft guidance for industry entitled ``Quality 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 This draft guidance is intended to provide sponsors with an 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 This draft guidance provides an overview of FDA's 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 16, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 (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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://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


