Journal
MABS
Volume 9, Issue 1, Pages 5-11Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/19420862.2016.1255520
Keywords
portion; IgG; INN; International Nonproprietary Name; monoclonal antibody; pharmacokinetics; recombinant; variants
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Funding
- French Higher Education and Research Ministry [LabEx MAbImprove ANR-10-LABX-53-01]
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In the context of a possible revision of the International Nonproprietary Names (INN) system of recombinant monoclonal antibodies, which is saturated, we propose several avenues of reflection driven by the primary goal of the INN, information of health-care professionals. Clinical considerations argue for an abandon of the substems A (target category) and B (origin category), which lengthen the INN without real added-value. On the contrary, new substems or suffixes are required to alert on the absence/presence of an Fc portion and/or multispecificity, which are essential from a pharmacological point of view. Moreover, we think it necessary to explicitly mention Fc variations since they could influence the pharmacology of these biopharmaceuticals, and hence their efficacy and side-effects. Besides indicating the subclass/isotype in the documents easily accessible to health care professionals, we propose to systematically describe both the natural variations (allotypes) by using the Gm (G marker) system, and the artificial variations by using a Ge (G engineering) system that is discussed here and could apply to all IgG constant domains (tentatively called the Fy portion).
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