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International nonproprietary names for monoclonal antibodies: an evolving nomenclature system

Guimaraes Koch, Sofia S; Thorpe, Robin; Kawasaki, Nana; Lefranc, Marie-Paule; Malan, Sarel; Martin, Andrew CR; Mignot, Gilles; ... Balocco, Raffaella; + view all (2022) International nonproprietary names for monoclonal antibodies: an evolving nomenclature system. mAbs , 14 (1) , Article 2075078. 10.1080/19420862.2022.2075078. Green open access

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Abstract

Appropriate nomenclature for all pharmaceutical substances is important for clinical development, licensing, prescribing, pharmacovigilance, and identification of counterfeits. Nonproprietary names that are unique and globally recognized for all pharmaceutical substances are assigned by the International Nonproprietary Names (INN) Programme of the World Health Organization (WHO). In 1991, the INN Programme implemented the first nomenclature scheme for monoclonal antibodies. To accompany biotechnological development, this nomenclature scheme has evolved over the years; however, since the scheme was introduced, all pharmacological substances that contained an immunoglobulin variable domain were coined with the stem -mab. To date, there are 879 INN with the stem -mab. Owing to this high number of names ending in -mab, devising new and distinguishable INN has become a challenge. The WHO INN Expert Group therefore decided to revise the system to ease this situation. The revised system was approved and adopted by the WHO at the 73rd INN Consultation held in October 2021, and the radical decision was made to discontinue the use of the well-known stem -mab in naming new antibody-based drugs and going forward, to replace it with four new stems: -tug, -bart, -mig, and -ment.

Type: Article
Title: International nonproprietary names for monoclonal antibodies: an evolving nomenclature system
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1080/19420862.2022.2075078
Publisher version: https://doi.org/10.1080/19420862.2022.2075078
Language: English
Additional information: © 2022 The Author(s). Published with license by Taylor & Francis Group, LLC. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: International Nonproprietary Name (INN), antibodies, antibody-based drugs, antibody-drug conjugates, biological drugs, biologics, nomenclature scheme, pharmaceuticals, safety, therapeutic antibodies, Antibodies, Monoclonal, Pharmaceutical Preparations, World Health Organization
UCL classification: UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > Div of Biosciences > Structural and Molecular Biology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > Div of Biosciences
URI: https://discovery.ucl.ac.uk/id/eprint/10149553
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