What’s In a Name? FDA and Non-Proprietary Names for Biologics/Biosimilars

Solving FDA Legal Challenges for the Life of a Life Sciences Company -1- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
What’s In a Name?
FDA and Non-Proprietary Names
for Biologics/Biosimilars
Michael A. Swit, Esq.
Vice President, Life Sciences
Presentation to the 11th Biosimilars &
Follow-on Biologics 2018 Americas
April 20, 2018
McLean, Virginia

Standard Disclaimers
• Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
• This presentation supports an oral briefing and
should not be relied upon solely on its own to
support any conclusion of law or fact.
• These slides are intended to provide general
educational information and are not intended to
convey legal advice.

Naming Process
• U.S. Adopted Name (USAN) Council –AMA,
American Pharmacists Assn., USP
– Independent of WHO and INN process
– Drug substances only
– Biologics –
• primary sequence –characteristics of the biopolymer
• if different glycosylation pattern – Greek suffix
• further elements – numbers (Interferon Alfa –2a)
• USP – monographs for drug products as well
– if official, name must be used by approved drug/biologic
• •If no official USP name, FDA picks

Arguments -- Con
• Five key ways drugs are tracked in U.S. – the generic
name is only one aspect of this
– NDC # -- Bar code
– Trade name -- Generic name
– Manufacturer
• Express Scripts to the FTC – we can track every drug
we paid for without reference to INN
• FDA to WHO in 2006
– rejects relying on non-proprietary names relative to
interchangeability
– not needed for AE/PV handling

Arguments -- Con
• Europe
– does not rely on INN for adverse event reporting
– INN is (usually) same for brand and biosimilar
– much greater penetration
• Negative Penetration – data show using different
INNs markedly reduces biosimilar utilization
– Australia
– Japan
– Europe – in cases where there are different INNs (e.g., Hospira’s
EPO zeta) – excluded from tenders
• Prefixes or suffixes – will confuse docs

Pro – Branded Views
• Amgen
– essential to traceability
– asserts naming does not impact utilization
– Physicians favor “similar name” to brand, with “additional
nomenclature” to make clear it is a biosimilar
• Pfizer
– Study – AE’s for small molecule drug with generic competition
• 14% of AE’s not traceable to manufacturer
• only 10% had NDC #’s; 30% of those were inaccurate
– 99% traceable to brand name of maker
– But, not all global jurisdictions – including FDA – can require a
brand name; thus, need a second identifier

FDA Actions
• August 2015 -- Draft Guidance on Naming (no longer
on FDA’s website) – can be accessed at:
– https://www.fdanews.com/ext/resources/files/08-15/8-15-Biological-Naming.pdf?1520774016
• August 2015 – Proposed Rule to change names of six
products:
– filgrastim-sndz (BLA 125553)  filgrastim-bflm = Zarxio® (Sandoz)
– filgrastim (BLA 103353)  filgrastim-jcwp = Neupogen ® (Amgen)
– tbo-filgrastim (BLA 125294)  filgrastim-vkzt = Granix® (Teva/Cephalon)
– pegfilgrastim (BLA 125031)  pegfilgrastim-ljfd = Neulasta ® (Amgen)
– epoetin alfa (BLA 103234)  epoetin alfa-cgkn = Epogen® (Amgen)
– infliximab (BLA 103772)  infliximab-hjmt = Remicade® (J&J)
NOTE: none changed yet

The Naming Guidance
• January 2017 – “Nonproprietary Naming of
Biological Products”
– https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation
/guidances/ucm459987.pdf
– Published in the January 13, 2017 Federal Register – 82 Fed. Reg. 4345..
• Bottom Lines –
– “proper name” = “core name” + unique suffix -- of 4
lower case letters -- that is “devoid of meaning”
• example: filgrastim + bflm
– applies to:
• innovator;
• biosimilar; and
• “related biological product”

FDA’s Rationale
• Will facilitate pharmacovigilance (PV)
• Heighten accurate identification of biologics by
health care practitioners (HCPs) and patients
• Suffixes should help preclude inadvertent
substitution of non-interchangeable products
• Will encourage routine use of suffixes in ordering,
prescribing, dispensing, recordkeeping, and PV
• Will avoid inaccurate perceptions of the safety and
efficacy of biologics

PV Problems Addressed by Guidance
• PV systems vary in their ability to differentiate between
biologics; current identifiers include:
– proper name, manufacturer, NDC number, Lot number, and billing
codes
• FDA: many systems can not distinguish between
different manufacturers using the same non-proprietary
name (NPN)
• NDC numbers – often not recorded in the clinical
setting or in billing
• Adverse event reports – also often lack brand names
and NDC numbers

Safe Use Goals Served by Naming Scheme
• Inadvertent substitution – seen as being minimized
by the Core/Suffix approach
– FDA -- concerned that physicians, based on their experience
with small-molecule drugs, where the NPNs cover drugs that
are interchangeable, will think they can substitute
• Facilitate use of the “Purple Book”

Naming Scheme Advances Practices and
Perceptions About Biologics
• Avoids inaccurate perceptions of safety and
effectiveness of biologics based on their licensure
pathway
– by applying it to both brand and biosimilar
• Applying to both brand and biosimilar also
– helps prevent a patient from getting a product other than that
which was prescribed
– facilitates manufacturer-specific PV

Developing a Proper Name
• Core name – if available, will use USAN Council
name for the relevant biological substance
– using same core name (e.g., filgrastim) among products with
same biological substance will also help ensure data are kept
together in databases
• contrast: tbo-filgrastim vs. filgrastim
• Suffix
– always will be attached by a hyphen
– if the core name has two parts, suffix gets attached to 2nd part:
• putonastim alfa-jnzl

Developing a Proper Name …
• When to submit: during IND or at BLA
submission
– up to 10 in order of preference
• Suffix requirements
– unique
– devoid of meaning
– 4 lower case letter; only 1 can repeat
– non-proprietary
– use hyphen
– “free of legal barriers that would restrict” use (e.g., trademarks)

Developing a Proper Name …
• Suffix prohibitions
– false or misleading
– includes numerals or symbols
– includes an abbreviation commonly used in clinical practice (e.g.,
bid, daw)
– contain or suggest any drug substance name or core name (e.g.,
nsln)
– resemble or be capable of being mistaken for a currently
marketed product (e.g., alli)
– resemble or connote the license holder
– be too similar to any other FDA-designated NPN suffix

Unresolved Naming Issues
• How to apply suffixes to interchangeable biosimilars
– note the Purple Book uses code “I” for interchangeable and “B”
for the “conventional” biosimilar
• How to deal with already-licensed biologics (other
than the Gang of 6 from the Aug. 2015 Proposed Rule)
– agency did say in guidance it would entertain prior approval
submissions for name changes for such products
• Using same suffix for all products by same company
– see Proposed Rule and how it treats Amgen
• Administrative issues that might be present for the
CDER-approved biologic NDAs that convert to BLAs
on March 23, 2020

Labeling
• Guidance – Labeling for Biosimilar Products –
March 2016 --
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidan
ces/ucm493439.pdf
• General view on clinical data
– “it is FDA’s view that biosimilar labeling should not include a
description of these data (clinical study of the biosimilar), given
that a clinical study supporting the licensure of the biosimilar
product would not be independently designed to demonstrate
the safety and efficacy of the product…”
– should only be included if necessary to inform safe and
effective use by an HCP
– reason – standard for approval is (a) highly similar and (b) no
clinically meaningful differences

Labeling …
• BUT – agency DOES want you to include:
– a “description of the clinical data that supported safety and
efficacy of the reference product (RP).”
– text does not need to be identical to RP labeling (contrast
Waxman-Hatch rules)
• CAVEAT: strong argument here that the Biosimilar BLA holder
must update labeling before the RP if Biosimilar learns of a
safety issue
• Guidance – contains detail on when to use both the
proprietary and NPN for the biosimilar in the
labeling – usually when:
– the “text is specific to the biosimilar product or refers solely to
the biosimilar product …”

Labeling …
• When to use the RP name:
– when studies or data derived from studies of RP are described,
should use RP name
• Should be specific to conditions of use (e.g., the
biosimilar only has certain approved indications)
• “Biosimilarity Statement” – agency recommends
including a statement, directly below the initial U.S.
approval date in Highlights section of labeling, that the
product is biosimilar to the reference product:
– Example: ZARXIO (filgrastim-sndz) is biosimilar* to
NEUPOGEN (filgrastim) for the indications listed.

Labeling …
• The Asterisk:
– ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN
(filgrastim) for the indications listed.
– * = footnote symbol, with footnote to be added at end of
Highlights section, above the Revision Date, that reads:
• *Biosimilar means that the biological product is approved
based on data demonstrating that it is highly similar to an
FDA-approved biological product, known as a reference
product, and that there are no clinically meaningful
differences between the biosimilar product and the
reference product

Questions?
➢ Call, e-mail or write:
San Diego, California 92130
m: 760-815-4762
e: mswit@fdacounsel.com
web: www.fdacounsel.com
➢ Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel

About Your Speaker
Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues for over 30
years. Before returning to his private law practice in late 2017, he served for 3 years as the chief
regulatory counsel at Illumina, Inc., the world’s leading developer of gene sequencing technologies.
Prior to that, Swit was a special counsel in the FDA Law Practice at the global law firm of
Duane Morris LLP, in its San Diego office. Before joining Duane Morris in March 2012, Swit served
for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and
regulatory consulting firm in the Life Sciences.
His expertise includes product development, compliance and enforcement, recalls and crisis
management, submissions and related traditional FDA regulatory activities, labeling and advertising,
and clinical research efforts for all types of life sciences companies, with a particular emphasis on
drugs, biologics, therapeutic biotech products, medical devices, and IVDs.
His FDA legal and regulatory work also has included tenures in private practice with McKenna &
Cuneo and Heller Ehrman, and as vice president, general counsel and secretary of Par
Pharmaceutical, a top public generic and specialty drug firm, where he helped spearhead the
company’s emergence from the Generic Drug Scandal. He also was, from 1994 to 1998, CEO of
FDANews.com, a premier publisher of regulatory newsletters and other specialty information
products for FDA-regulated firms.
He has taught and written on many topics relating to FDA regulation and associated commercial
activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his
A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at
Emory University.

What’s In a Name? FDA and Non-Proprietary Names for Biologics/Biosimilars

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