HPE HPE Fresenius Kabi handbook - Page 7

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 hospitalpharmacyeurope.com | 2019 | 7