NOMENCLATURE
Naming conventions
and nomenclature
Although there is a trend towards establishing differentiation between biologic originators
and biosimilars through naming, there is still lack of global consensus
Lluís Puig MD PhD
Department of
Dermatology, Hospital de
la Santa Creu i Sant Pau,
Autonomous University
of Barcelona, Barcelona,
Spain
A drug’s name is required to prescribe any
medicine and has a strong impact on product
traceability for accounting and pharmacovigilance
purposes, especially in the setting of switching or
substitution of originator biologics and biosimilars
(interchangeability in US Food and Drug
Administration (FDA) terms) but there is no accepted
worldwide naming convention for biosimilars and
reference biologics.
How should biosimilars be named?
Naming should:
• Show that the reference biologic and biosimilar are
highly similar, but not identical
• Differentiate the biosimilar from its reference
product
• Differentiate biosimilar A from biosimilar
B, C, D, etc.
Currently this is handled on a country-by-country
basis.
Europe
The concept of a single non-proprietary name to
be used worldwide for active pharmaceuticals
was established by the World Health Organization
(WHO) in 1950 and became operational in 1953.
In the European Union, biosimilars and reference
biologics are identified by the WHO international
non-proprietary name (INN), followed by the brand
FIGURE 1
Summary of guidlines for naming conventions
WHO
• INN guideline with list
of assigned INN names
WHO/EMP/RHT/TSN/
2016.1 6
• WHO position on
biologic qualifiers
(INN Working
Document 14.342) 4
Current position:
Random alphabetic
suffix plus check
sum for all biologics;
independent element
used in conjunction with
the INN
FDA
• Non-proprietary naming
of biological products
(2017) 5
• Labeling for biosimilar
products. Guidance for
industry 7
Current position:
Four-lower case letter,
unique suffix added to
the INN of biologics.
Company can submit
several suffixes with order
of preference from which
FDA will choose one.
Current examples are with
and without meaning (for
example, -sndz vs -dyyb)
EMA
No position expressed
or published
name. Brand names are often the primary identifiers
for reporting adverse events, and since 2010, the
European Union legislation requires that member
states take measures to ensure that trade names are
used in health records and adverse event reports, 1
but their use is often inaccurate. 2 The European
Medicines Agency’s (EMA) solution of identifying
products by a ‘trade name’ comprising the INN
and the manufacturer’s name 3 in the absence of a
brand name would not work in the USA because
this concatenation is not a recognised trade name,
and the separate manufacturer name field is not
routinely captured in health records or adverse
events reporting systems.
WHO vs FDA guidelines
The WHO guidelines propose a system in which
a randomly generated four-consonant suffix or
biological qualifier (BQ), devoid of meaning, is
assigned to all biological products. 4 The WHO
proposal both acknowledges the biosimilarity
concept and provides a mechanism for traceability,
which bears some resemblance to the FDA’s
proposed biosimilar naming scheme first announced
in August 2015 and published in 2017. 5 Figure 1
summarises the positions on naming of biosimilars.
The suffix
According to the FDA guidance, the proposed suffix
should be:
• unique
• devoid of meaning
• composed of four lowercase letters, of which at
least three are distinct
• non-proprietary
• attached to the core name with a hyphen
• free of legal barriers that would restrict its usage.
The first biosimilar approved in the United States,
Zarxio (from Sandoz), was assigned an INN with a
suffix related to the manufacturer’s name: filgrastim-
sndz. Non-proprietary naming of biosimilars
approved after Zarxio followed the current FDA
guidance, for example: Inflectra (infliximab-dyyb);
Erelzi (etanercept-szzs); Amjevita (adalimumab-atto);
Renflexis (infliximab-abda); Cyltezo (adalimumab-
adbm); Mvasi (bevacizumab-awwb); Ogivri
(trastuzumab-dkst); Ixifi (infliximab-qbtx); Retacrit
(epoetin alfa-epbx). Remicade, marketed by Janssen in
the US, would be named infliximab-hjmt according
to this guidance and infliximab-jnsn if the suffix were
manufacturer-derived. 8
Many stakeholders (including pharmacists’
associations and manufacturers of both references
and biosimilars) have criticised random non-
meaningful suffixes. While suffixes associated
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