The INN global nomenclature of biological medicines: A continuous challenge. (July 2019)

• Record Type: Journal Article
• Authors: Robertson, James S.; Chui, Wai-Keung; Genazzani, Armando A.; Malan, Sarel F.; López de la Rica Manjavacas, Ana; Mignot, Gilles; Thorpe, Robin; Balocco, Raffaella; Rizzi, Menico
• Is Part Of: Biologicals. Volume 60(2019)
• Page Start: 15
• Page End: 23
• Publication Date: 2019-07
• Subjects: International non-proprietary name -- Biological medicines -- Drug nomenclature; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2019.05.006
• Languages: English
• ISSNs: 1045-1056

Abstract

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.