[Federal Register Volume 85, Number 23 (Tuesday, February 4, 2020)]
[Notices]
[Pages 6201-6203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5473]


Promotional Labeling and Advertising Considerations for 
Prescription Biological Reference and Biosimilar Products--Questions 
and Answers; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Promotional Labeling and Advertising Considerations for Prescription 
Biological Reference and Biosimilar Products--Questions and Answers.'' 
FDA is issuing this guidance to provide manufacturers, packers, 
distributors, and their representatives (firms) with information to 
consider when developing FDA-regulated promotional labeling and 
advertisements (promotional materials) for prescription reference and 
biosimilar products licensed under the Public Health Service Act (PHS 
Act). Although the guidance covers promotional issues involving both 
reference and biosimilar products, some questions and answers are 
focused on only biosimilar product promotional materials. The guidance 
does not discuss considerations unique to promotional materials for 
interchangeable biosimilars.

DATES: Submit either electronic or written comments on the draft 
guidance by April 6, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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-2019-D-5473 for ``Promotional Labeling and Advertising 
Considerations for Prescription Biological Reference and Biosimilar 
Products--Questions and Answers.'' 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

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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 the draft 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 the office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Pepinsky, Office of 
Prescription Drug Promotion, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 
3248, Silver Spring, MD 20993-0002, 301-796-1200, email [email protected]; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Promotional Labeling and Advertising Considerations for 
Prescription Biological Reference and Biosimilar Products--Questions 
and Answers.'' The draft guidance addresses questions firms may have 
when developing FDA-regulated promotional materials for prescription 
reference products \1\ licensed under section 351(a) of the PHS Act (42 
U.S.C. 262(a)) and prescription biosimilar products \2\ licensed under 
section 351(k) of the PHS Act.
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    \1\ The term reference product means the single biological 
product licensed under section 351(a) of the PHS Act against which a 
biological product is evaluated in an application submitted under 
section 351(k) of the PHS Act (42 U.S.C. 262(i)(4)).
    \2\ In the guidance, the terms biosimilar and biosimilar product 
refer to a product that FDA has determined to be biosimilar to the 
reference product (see section 351(i)(2) and (k)(2) of the PHS Act) 
(42 U.S.C. 262(i)(2) and (k)(2))).
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    The Biologics Price Competition and Innovation Act of 2009 created 
an abbreviated licensure pathway for biological products shown to be 
biosimilar to or interchangeable \3\ with an FDA-licensed reference 
product. Specifically, section 351(k) of the PHS Act outlines (among 
other things) the requirements for demonstrating biosimilarity and 
defines a biosimilar as a biological product that is highly similar to 
the reference product notwithstanding minor differences in clinically 
inactive components and for which there are no clinically meaningful 
differences between the biological product and the reference product in 
terms of safety, purity, or potency. As the number of licensed 
biosimilar products increases, FDA expects an increase in promotion 
involving reference products and biosimilar products. FDA is providing 
this guidance to address questions firms may have when developing FDA-
regulated promotional materials for their reference products or 
biosimilar products. The guidance discusses considerations for 
presenting data and information about reference or biosimilar products 
in these promotional materials to help ensure they are truthful and 
non-misleading as required under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) and FDA's implementing regulations.\4\
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    \3\ In the guidance, the terms interchangeable biosimilar and 
interchangeable product refer to a biosimilar product that FDA has 
determined to be interchangeable with the reference product (see 
section 351(i)(3) and (k)(4) of the PHS Act).
    \4\ See sections 201(n) and 502(a) and (n) of the FD&C Act (21 
U.S.C. 321(n) and 352(a) and (n)); 21 CFR 1.21(a) and 202.1(e)(5)).
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    The draft guidance includes the following considerations for 
developing promotional materials for reference products and biosimilar 
products:
     Identifying reference products and biosimilar products;
     Presenting information from the studies conducted to 
support licensure of the reference product in biosimilar product 
promotional materials when the information is included in the FDA-
approved labeling of both the reference and the biosimilar products;
     Presenting data or information from the studies conducted 
to support a demonstration of biosimilarity in biosimilar product 
promotional materials when the data or information is not included in 
the FDA-approved labeling for the biosimilar product;
     Presenting comparisons between a reference product and a 
biosimilar product; and
     Submitting promotional materials to FDA.
    The guidance also provides examples to illustrate some of the 
considerations outlined in the guidance.
    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 current thinking of FDA on ``Promotional 
Labeling and Advertising Considerations for Prescription Biological 
Reference and Biosimilar Products--Questions and Answers.'' 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.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved FDA collections 
of information. 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. 3501-3521). The collections of 
information in 21 CFR 202.1 have been approved under OMB control number 
0910-0686; the collections of information in the guidance for industry 
``Medical Product Communications That Are Consistent With the Food and 
Drug Administration Required Labeling--Questions and Answers'' have 
been approved under OMB control number 0910-0856; the collections of 
information in 21 CFR 601.12 related to submissions of labeling changes 
and of advertisements and promotional labeling have been approved under 
OMB control number 0910-0338; and the collection of information 
resulting from the submission of Form FDA 2253 has been approved under 
OMB control number 0910-0001.

III. Request for Comment on Other Issues for Consideration

    FDA is interested in additional issues related to the promotion of 
biological products licensed under section 351(k) of the PHS Act and 
their reference products licensed under section 351(a) of the PHS Act. 
One area of interest focuses on considerations about what firms may 
want to convey in promotional materials regarding products licensed as 
interchangeable to a reference product. FDA is specifically seeking 
input on the following:
    (1) What promotional considerations unique to interchangeable 
biosimilars exist, if any?
    (2) What other considerations can help promotional materials convey 
truthful and non-misleading information about interchangeable

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products to various audiences (e.g., patients, healthcare providers)?

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02100 Filed 2-3-20; 8:45 am]
BILLING CODE 4164-01-P