8884 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / 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. 

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This draft guidance describes 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 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particular, the draft guidance refers to 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In addition, this draft guidance 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the draft guidance.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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/ 

BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm, or http:// 

www.regulations.gov. 

Dated: February 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[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] 

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 selfaddressed 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 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 8885 

1Section 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). 

2For 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. 

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. 

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/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/ 

BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/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 

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 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 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. 


sroberts on DSK5SPTVN1PROD with NOTICES