[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52296-52299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21383]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1543]


Nonproprietary Naming of Biological Products; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Nonproprietary Naming of Biological Products.'' The draft guidance 
describes our current thinking on the need for biological products 
licensed under the Public Health Service Act (PHS Act) to bear a 
nonproprietary name that includes an FDA-designated suffix. Our current 
thinking is that shared nonproprietary names are not appropriate for 
all biological products. There is a need to clearly identify biological 
products to improve pharmacovigilance, and, for the purposes of safe 
use, to clearly differentiate among biological products that have not 
been determined to be interchangeable. Accordingly, for biological 
products, we intend to designate a nonproprietary name that includes a 
suffix composed of four lowercase letters. Each suffix will be 
incorporated in the nonproprietary name of the product. This naming 
convention is applicable to biological products previously licensed and 
newly licensed under the PHS Act. The nonproprietary name designated 
for originator biological products, related biological products, and 
biosimilars will include a unique suffix. However, FDA is considering 
whether the nonproprietary name for an interchangeable product should 
include a unique suffix, or should share the same suffix as its 
reference product. FDA invites comment on the draft guidance and 
solicits comments on ways to improve active pharmacovigilance systems 
for the purposes of monitoring the safety of biological products.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance, including responses to the questions in this notice, by 
October 27, 2015. Submit either electronic or written comments on the 
collection of information by October 27, 2015.

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, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002; or to 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 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

[[Page 52297]]

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Nonproprietary Naming of Biological Products.'' The draft 
guidance describes our current thinking on the need for biological 
products licensed under section 351(a) or 351(k) of the PHS Act (42 
U.S.C. 262(a) or 262(k)), as added by the Biologics Price Competition 
and Innovation Act of 2009 (BPCI Act),\1\ to bear a nonproprietary name 
that includes an FDA-designated suffix. Our current thinking is that 
shared nonproprietary names are not appropriate for all biological 
products. There is a need to clearly identify biological products for 
the purpose of pharmacovigilance, and, for the purposes of safe use, to 
clearly differentiate among biological products that have not been 
determined to be interchangeable. Accordingly, for biological products, 
we intend to designate a nonproprietary name that includes a suffix 
composed of four lowercase letters. Each suffix will be incorporated in 
the nonproprietary name of the product. This naming convention is 
applicable to biological products previously licensed and newly 
licensed under sections 351(a) and 351(k) of the PHS Act. The 
nonproprietary name designated for originator biological products, 
related biological products, and biosimilar products will include a 
unique suffix. However, as discussed in section IV.C. of the guidance, 
FDA is seeking comment on whether the nonproprietary name for an 
interchangeable product should include a unique suffix, or should share 
the same suffix as its reference product.
---------------------------------------------------------------------------

    \1\ The BPCI Act was enacted as part of the Patient Protection 
and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
---------------------------------------------------------------------------

    By differentiating biological products from one another that have 
not been determined by the FDA to be interchangeable, this naming 
convention is intended to help minimize inadvertent substitution. 
Inadvertent substitution may lead to unintended alternating or 
switching of biological products that have not been determined by FDA 
to be interchangeable. A naming convention that differentiates among 
biological products also could help facilitate pharmacovigilance for 
all biological products. By applying this naming convention to all 
biological products, this approach is intended to: (1) Encourage 
routine use of designated suffixes in ordering, prescribing, 
dispensing, and recordkeeping practices and (2) avoid inaccurate 
perceptions of the safety and effectiveness of biological products 
based on their licensure pathways.
    The draft guidance provides information to industry, the health 
care community, other regulatory agencies, and the public on our 
rationale for this naming convention. The draft guidance also is 
intended to assist applicants and application holders in proposing the 
suffix to be used as part of a biological product's nonproprietary 
name. The nonproprietary name designated by FDA in the license for a 
biological product licensed under the PHS Act is its ``proper name,'' 
and the term ``proper name'' is used throughout the draft guidance (see 
section 351(a)(1)(B)(i) of the PHS Act and 21 CFR 600.3(k)).
    We invite comment on the draft guidance, including potential 
approaches for designating and incorporating suffixes retrospectively 
and prospectively into the nonproprietary names of all biological 
products. We also solicit comments on ways to improve active 
pharmacovigilance systems for the purposes of monitoring the safety of 
biological products. In providing comments, please consider the 
following:
    1. What are the potential benefits and challenges of designating a 
suffix in the proper name of a biological product that is:
    [cir] Devoid of meaning versus meaningful (e.g., a suffix derived 
from the name of the license holder)
    [cir] unique to each biological product versus unique to each 
license holder and shared by each biological product manufactured by 
that license holder.
    In your comments, please address how each option would impact the 
following: Safe use of biological products; pharmacovigilance; and 
market acceptance and uptake for certain products.
    2. What would be the potential benefits and challenges for an 
interchangeable product \2\ to share the same suffix as designated in 
the proper name of the reference product? Your response should consider 
that FDA's publicly available electronic resource, the Purple Book,\3\ 
will identify biological products determined by FDA to be biosimilar to 
or interchangeable with a reference product. If an interchangeable 
product does share the same suffix as the reference product, how would 
this impact your responses to question 1, including pharmacovigilance?
---------------------------------------------------------------------------

    \2\ Interchangeable product means a biological product that has 
been shown to meet the standards described in section 351(k)(4) of 
the PHS Act and may be substituted for the reference product without 
the intervention of the health care provider who prescribed the 
reference product (see section 351(i)(3) of the PHS Act).
    \3\ The Purple Book: Lists of Licensed Biological Products With 
Reference Product Exclusivity and Biosimilarity or 
Interchangeability Evaluation is available on FDA's Web site at 
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm.
---------------------------------------------------------------------------

    3. Would there be additional benefits or challenges if the suffix 
designated in the proper name of a biosimilar product that is 
subsequently determined to be interchangeable were changed to that of 
the reference product upon a determination of interchangeability? Would 
there be benefits or challenges to allowing the manufacturer of the 
biosimilar product that is subsequently determined to be 
interchangeable to have the option of retaining its original suffix or 
adopting the same suffix as the reference product?
    4. How could FDA and/or other Federal partners improve active 
pharmacovigilance systems for purposes of monitoring the safety of 
biological products? For example, because NDC numbers are not routinely 
recorded in billing and patient records in many clinical settings in 
which biological products are dispensed and administered, are there 
other identifiers besides distinguishable nonproprietary names that are 
routinely accessible by active pharmacovigilance systems and could 
enable as good as or better pharmacovigilance? How can FDA and/or other 
Federal partners help ensure that a distinguishable identifier for each 
biological product would be captured at the point of dispensing or 
administration to the patient and be routinely accessible in systems 
used for pharmacovigilance?
    5. What process and reasonable timeframe should FDA use to 
designate a suffix to include in the nonproprietary name of a 
previously licensed biological product?
    6. What criteria should FDA use to prioritize retrospective 
application of this naming convention to previously licensed biological 
products?
    7. What are the expected time frames for sponsors of previously 
licensed biological products to distribute products that conform to 
this naming convention after approval of a labeling supplement?
    8. What strategies could FDA use to enhance stakeholders' 
understanding of and education about this naming convention?
    9. FDA notes that this naming convention (i.e., use of a suffix) 
has

[[Page 52298]]

some similarities to the World Health Organization (WHO) proposal, 
``Biological Qualifier--An INN Proposal.'' At the time of publication 
of this draft guidance, WHO was still evaluating the comments received 
on its proposal. If WHO adopts a Biological Qualifier proposal, how 
should the biological qualifiers generated by WHO be considered in the 
determination of FDA-designated proper names for the biological 
products within the scope of this guidance?
    We are continuing to consider the transition provisions of section 
7002(e)(2) through (e)(4) of the BPCI Act that apply to biological 
products submitted or approved under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), including how those provisions may impact the 
nonproprietary naming of products to which those provisions apply. We 
invite comment from all stakeholders on the application of this naming 
convention to biological products approved under the FD&C Act.
    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 nonproprietary 
naming of biological products, including biosimilar products and 
interchangeable 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.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    The draft guidance proposes a new collection of information by 
requesting information from applicants and application holders to 
propose a suffix composed of four lowercase letters to be included in 
the ``proper name.'' The ``proper name'' is designated by FDA at the 
time of licensure for biological products submitted under section 
351(a) of the PHS Act and for biosimilar products and interchangeable 
products submitted under section 351(k) of the PHS Act. The applicant 
should also include information that the proposed suffix meets the 
factors described in the draft guidance. For the prospective 
application of this naming convention, our evaluation will generally 
occur during the investigational new drug application phase and will 
also be incorporated into the review of the marketing application.
    The draft guidance also refers to a previously approved collection 
of information found in FDA regulations that is expected to change as a 
result of the draft guidance and the retrospective application of the 
naming convention. The collection of information is related to the 
following: The submission of a biologics license application (BLA) and 
changes to an approved application, which is covered under part 601 (21 
CFR part 601) and approved under OMB control number 0910-0338. As a 
result of the draft guidance, the estimated number of additional 
responses for the annual burden for changes to an approved application 
under Sec.  601.12 would be increased by approximately 25 responses.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations that are not expected to change 
as a result of the draft guidance. The collection of information is 
related to the following: The submission of a BLA under section 351(k) 
of the PHS Act (biosimilar products and interchangeable products), 
which is approved under OMB control number 0910-0719.
    FDA estimates the burden of this collection of information for the 
prospective application of the naming convention as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Information for the Proposed                  20               2              40               6             240
 Proper Name for Biological
 Products Submitted Under
 Section 351(a) of the PHS Act..
Information for the Proposed                   3               2               6               6              36
 Proper Name for Biosimilar
 Products and Interchangeable
 Products Submitted Under
 Section 351(k) of the PHS Act..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             276
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 52299]]

    As indicated in table 1, we estimate that we will receive a total 
of approximately 40 requests annually for the proposed ``proper name'' 
for biological products submitted under section 351(a) of the PHS Act 
and 6 requests annually for the proposed ``proper name'' for biosimilar 
products and interchangeable products submitted under section 351(k) of 
the PHS Act. The average burden per response (hours) is based on the 
Agency's experience with similar information collection requirements.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: August 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21383 Filed 8-27-15; 8:45 am]
BILLING CODE 4164-01-P