International nonproprietary names for monoclonal antibodies: an evolving nomenclature system
Sofia S. Guimaraes Koch,
Robin Thorpe,
Nana Kawasaki,
Marie-Paule Lefranc,
Sarel Malan,
Andrew C.R. Martin,
Gilles Mignot,
Andreas Plückthun,
Menico Rizzi,
Stephanie Shubat,
Karin Weisser,
Raffaella Balocco
Affiliations
Sofia S. Guimaraes Koch
INN Unit, WHO, Geneva, Switzerland
Robin Thorpe
Welwyn, UK
Nana Kawasaki
Yokohama City University, Yokohama, Japan
Marie-Paule Lefranc
Institut Universitaire de France, Université de Montpellier, Laboratoire d’ImmunoGénétique Moléculaire LIGM, Institut de Génétique Humaine IGH, Montpellier, France
Sarel Malan
School of Pharmacy, University of the Western Cape, Bellville, South Africa
Andrew C.R. Martin
Institute of Structural & Molecular Biology, Division of Biosciences, University College London, London, UK
Gilles Mignot
Nice, France
Andreas Plückthun
Department of Biochemistry, University of Zurich, Zurich, Switzerland
Menico Rizzi
Department of Pharmaceutical Sciences, University of Piemonte Orientale, Novara, Italy
Stephanie Shubat
United States Adopted Names (USAN) Program, Chicago, Illinois, USA
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.