奥马佐单抗
生物仿制药
单克隆抗体
药理学
药代动力学
免疫球蛋白E
医学
抗体
免疫学
内科学
作者
Yanchao Wang,Zheng Chen,Zhuang Chen,Qiang Fu,Baohong Zhang,Yanling Bian,Nianmin Qi,Zhu Jun
标识
DOI:10.1016/j.ejps.2022.106292
摘要
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.
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