Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 34141 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–0643] 

Labeling for Biosimilar Products; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Labeling 

for Biosimilar Products.’’ This guidance 

is intended to help applicants develop 

draft labeling for proposed biosimilar 

products. The recommendations for 

prescription drug labeling in this 

guidance pertain only to the prescribing 

information (commonly referred to as 

the package insert), except for certain 

recommendations pertaining to FDAapproved patient labeling (e.g., Patient 

Information, Medication Guide, and 

Instructions for Use). This guidance 

provides an overview of FDA’s 

recommendations for labeling for 

biosimilar products. This guidance 

finalizes the draft guidance issued on 

April 4, 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 19, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–0643 for ‘‘Labeling for 

Biosimilar Products; Guidance for 

Industry; Availability.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Sandra Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 6522, 

Silver Spring, MD 20993, 301–796– 

1042; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7268, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Labeling for Biosimilar Products.’’ The 

Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act), 

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 for biological 

products demonstrated to be biosimilar 

to or interchangeable with an FDAlicensed reference product. Section 

351(k) of the Public Health Service Act 

(PHS Act) (42 U.S.C. 262(k)), added by 

the BPCI Act, sets forth the 

requirements for an application for a 

proposed biosimilar product and an 

application or supplement for a 

proposed interchangeable product. 

Under section 351(k) of the PHS Act, a 


sradovich on DSK3GMQ082PROD with NOTICES
34142 Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 

proposed biological product that is 

demonstrated to be biosimilar to a 

reference product can rely on certain 

existing scientific knowledge about the 

safety, purity, and potency of the 

reference product to support licensure, 

and this is reflected in the approach to 

biosimilar product labeling. 

In this guidance, FDA outlines its 

recommendations for biosimilar product 

labeling. A demonstration of 

biosimilarity means, among other 

things, that FDA has determined that 

there are no clinically meaningful 

differences between the proposed 

product and the reference product in 

terms of safety, purity, and potency. 

Accordingly, biosimilar applicants 

should incorporate relevant data and 

information from the reference product 

labeling, with appropriate modifications 

as recommended in the guidance. 

This guidance finalizes the draft 

guidance issued on April 4, 2016. 

Changes made to the guidance took into 

consideration the comments received, as 

well as requests regarding the 

requirements for and/or contents of 

biosimilar labeling made in the 

following citizen petitions: FDA–2015– 

P–2000 (submitted by AbbVie, Inc.), 

FDA–2015–P–4529 (submitted by a 

group of institutional investors 

including the United Auto Workers 

(UAW) Retiree Medical Benefits Trust), 

and FDA–2015–P–0776 (submitted by 

the Pharmaceutical Research and 

Manufacturers of America and the 

Biotechnology Industry Organization) 

(these citizen petitions are available at 

https://www.regulations.gov). Editorial 

changes were made primarily for 

clarification. 

In the Federal Register of April 4, 

2016 (81 FR 19194), FDA announced the 

availability of the draft guidance for 

industry ‘‘Labeling for Biosimilar 

Products.’’ FDA requested comment on 

whether FDA-approved patient labeling 

(e.g., Patient Information, Medication 

Guide, and Instructions for Use) should 

include a biosimilarity statement similar 

to the statement described in section 

IV.C.1 of the draft guidance. Several 

comments agreed with inclusion of the 

biosimilarity statement; one comment 

disagreed. FDA considered the 

comments received, but decided not to 

recommend inclusion of a biosimilarity 

statement in FDA-approved patient 

labeling at this time. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Labeling for 

Biosimilar Products.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information for 

the submission of a biologics license 

application under section 351(k) of the 

PHS Act have been approved under 

OMB control number 0910–0719; the 

collections of information in 21 CFR 

201.56 and 201.57 for the submission of 

labeling have been approved under 

OMB control number 0910–0572; the 

collections of information in 21 CFR 

part 208 for Medication Guides have 

been approved under OMB control 

number 0910–0393; the collections of 

information in 21 CFR 312.47 for 

meetings with FDA have been approved 

under OMB control number 0910–0014; 

the collections of information in 21 CFR 

part 600 for the submission of adverse 

experience reporting for licensed 

biological products and general records 

have been approved under OMB control 

number 0910–0308; and the collections 

of information in 21 CFR part 601 for 

the submission of labeling in a biologics 

license application or supplement to a 

biologics license application have been 

approved under OMB control number 

0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: July 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15391 Filed 7–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2326] 

Field Alert Report Submission: 

Questions and Answers; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Field 

Alert Report Submission: Questions and 

Answers.’’ This draft guidance, when 

finalized, will provide the Agency’s 

current thinking regarding the 

requirements for submission of field 

alert reports (FARs) by applicants of 

new drug applications (NDAs) and 

abbreviated new drug applications 

(ANDAs) and will outline FDA’s 

recommendations for FAR submissions 

to help increase their consistency and 

relevancy. The draft guidance also 

addresses certain frequently asked 

questions about FARs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 17, 2018 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 


sradovich on DSK3GMQ082PROD with NOTICES