New INN monoclonal antibody (mAb) nomenclature scheme

International Nonproprietary Names scheme for monoclonal antibody (mAb)

31 October 2021

| Publication

Overview

Group 1 -tug for unmodified immunoglobulins

Monospecific full length and Fc unmodified immunoglobulins of any class. Molecules which might occur as such in the immune system. Including:

- IgG, IgA, IgM, IgD, IgE

- only allelic variants

- Glycoengineering without mutation

- C-terminal lysine deletion without any other mutation in the Fc region

Group 2 -bart for antibody artificial

Monospecific full length immunoglobulins with engineered constant domains (CH1/2/3).

Monospecific full length immunoglobulins that contain any point mutation introduced by engineering for any reason anywhere (hinge, new glycan attachment site, mixed allelic variants which would not occur in nature, altered complement binding, altered FcRn binding, altered Fc-gamma receptor binding, etc.)

e.g. IGHG4 with S>P mutation, stabilized IgA

Group 3 -mig for multi-immunoglobulin

Bi- and multi-specific immunoglobulins regardless of the format, type or shape (full length, full length plus, fragments)

Group 4 -ment for fragment

All monospecific domains, fragments of any kind, derived from an immunoglobulin variable domain

(all monospecific constructs that do not contain an Fc domain)

WHO Team

Access to Medicines and Health Products (MHP), Health Product Policy and Standards (HPS), INN and Classification of Medical Products (INN)

Editors

Programme on International Nonproprietary Names (INN)

Number of pages

Reference numbers

WHO Reference Number: INN Working Document 21-531