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This draft guidance is being issued 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The draft guidance, when finalized, will 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This draft guidance describes 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particular, the draft guidance refers to 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
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: 

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 

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. 2012–3549 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. 

SUMMARY: 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. 


sroberts on DSK5SPTVN1PROD with NOTICES