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Biologicals. 2019 Jul;60:15-23. doi: 10.1016/j.biologicals.2019.05.006. Epub 2019 May 23.

The INN global nomenclature of biological medicines: A continuous challenge.

Author information

1
Independent Expert, United Kingdom.
2
Department of Pharmacy, National University of Singapore, Singapore.
3
Department of Pharmaceutical Sciences, University of Piemonte Orientale, Novara, Italy.
4
School of Pharmacy, University of the Western Cape, Bellville, South Africa.
5
Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
6
Independent Expert, France.
7
INN Programme, TSN/RHT/MVP, World Health Organization, Geneva, Switzerland.
8
Department of Pharmaceutical Sciences, University of Piemonte Orientale, Novara, Italy. Electronic address: menico.rizzi@uniupo.it.

Abstract

Medicines are assigned International Nonproprietary Names (INN) by the World Health Organization (WHO), pursuing the aim to increase patient safety. Following scientific developments in drug discovery and biotechnology, the number of biological medicines is constantly growing and a surge in INN applications for them has been observed. Pharmacologically active biological substances have a complex structure and mechanism of action posing new challenges in selecting names that appropriately reflect such properties. As a consequence, existing nomenclature naming schemes may need to be revised and new ones developed. This review reports on the recently implemented policies for naming fusion proteins, monoclonal antibodies, advanced therapy substances that cover gene and cell therapy, virus-based therapies as well as vaccines and vaccine-like substances. Different approaches, based on the use of a one-word versus a two-word naming scheme, have been developed for different categories of biological substances highlighting a major and still not completely resolved issue, i.e. how to assign a name that is both informative, short and euphonic.

KEYWORDS:

Biological medicines; Drug nomenclature; International non-proprietary name

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