International nonproprietary names for monoclonal antibodies: an evolving nomenclature system
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Date
2022
Journal Title
Journal ISSN
Volume Title
Publisher
Taylor and Francis
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.
Description
Keywords
International Nonproprietary Name (INN), Nomenclature scheme, Pharmaceutical, Safety
Citation
Guimaraes Koch, S. S. et al. (2022) International nonproprietary names for monoclonal antibodies: an evolving nomenclature system, mAbs, 14:1, 2075078, DOI: 10.1080/19420862.2022.2075078