Omalizumab is an anti-IgE monoclonal antibody (mAb) approved for the treatment of moderate-to-severe asthma. Herein, we report physicochemical, biological, pharmacological, and toxicological characteristics of an Omalizumab biosimilar mAb named KA. We show that KA and its originator present only minimum differences. Their charge heterogeneity and primary, secondary structures are similar. The two molecules are comparable regarding in vitro activity, including molecular binding and cell-based inhibition. Pharmacological and toxicological properties were assessed using a mouse model of allergy and cynomolgus monkeys, and we determined that the efficacy, safety, and pharmacokinetic characteristics of KA are comparable to its originator. Our data, which demonstrated that KA has similar activity to the Omalizumab reference product in relevant preclinical models, calls for a clinical evaluation of its bio-similarity.

Asthma

Anti-IgE

Omalizumab

Biosimilar

Preclinical

glutamic oxaloacetic transaminase

surface plasmon resonance

capillary isoelectric focusing

coefficients of variation

enzyme linked immunosorbent assay

good laboratory practice

glutamate protease C

Hanks balanced salt solution

Hanks’ balanced salt solution with 0,01 M HEPES

N-2-hydroxyethylpiperazine-N-ethane-sulphonic acid

high performance liquid chromatography

horseradish peroxidase

Institutional Animal Care and Use Committee

International Council for Harmonization

morpholine ethane sulfonic acid

NOD-PrkdcscidIl2rgem1/Smoc

nuclear factor of activated T cells

National Medical Products Administration

peripheral blood mononuclear cell

phosphate buffered saline

peptide N-glycosidase F

polyvinylidene difluoride

3,3 ', 5,5′ tetramethylbenzidine

ultra-performance liquid chromatography

© 2022 The Authors. Published by Elsevier B.V.