Following the introduction of biosimilars, naming conventions for biologicals have been introduced, in part to support pharmacovigilance.
The World Health Organization (WHO) first introduced the concept of a biological qualifier for naming biologicals back in 2014 [1]. In the European Union, both the brand name and International Nonproporietary Name (INN) are used to identify the specific biological product, whether it is an originator product or a biosimilar [2]. While the US Food and Drug Administration (FDA) introduced final guidance on the non-proprietary naming of biological products in 2017 [3].
The FDA guidance assigns a non-proprietary name for all originator biologicals, related biologicals and biosimilars that includes an ‘FDA-designated suffix’. The ‘proper name’ will consist of a combination of the ‘core name’ and distinguishable suffix, which will be ‘devoid of meaning’ and be ‘composed of four lowercase letters’.
Researcher Criswell Lavery and colleagues investigated whether healthcare providers were familiar with key concepts surrounding biosimilars and the FDA 4 character suffix, as well as their perceptions towards the perceived value of the naming guidance in clinical practice [4]. This was carried out by means of a 2-week survey sent to prescribers and other healthcare administrators, including pharmacists, nurses and medical coders, in the Philadelphia area.
The results showed that knowledge about biosimilars was generally poor. In fact, of the 456 respondents, only 52% correctly identified that a biosimilar differed from a generic drug. While 67% reported using the brand name in clinical practice to distinguish between biosimilars and reference products, with only a minority (30%) of respondents reporting regular use of the 4-character suffix to identify biologicals. The majority of respondents (68%) indicated a neutral response when asked if the 4-character suffix promoted medical errors. Most prescribers (76%) disagreed that the 4-character suffix affected their decision to use biosimilars.
The authors concluded that their results ‘suggest a knowledge gap with regard to biosimilars and lack of consensus about the usefulness of employing the 4-character suffix in clinical practice’. They added that ‘the lack of overall familiarity with biosimilars may also have contributed to a lack of comfort with the naming convention.’
Conflict of interest
The authors of the research paper [4] declared that they are all employees of pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [4].
Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.
Readers interested to learn more about naming of biologicals and biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Naming and labelling of biologicals – a survey of US physicians’ perspectives
US pharmacists’ views on the naming and labelling of biologicals
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal platform – please send us your submission here.
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| LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
1. GaBI Online - Generics and Biosimilars Initiative. WHO issues draft proposal for its biological qualifier [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Policies-Legislation/WHO-issues-draft-proposal-for-its-biological-qualifier
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar naming conventions around the world [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-naming-conventions-around-the-world
3. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
4. Lavery C, Olave M, Leonard C, et al. Knowledge of biosimilars and perceptions of biosimilar naming conventions in clinical practice [abstract]. Arthritis Rheumatol. 2020;72(suppl 10).
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