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Purpose: To compare the pharmacokinetics of APZ001 antibody with those of cetuximab (Erbitux®) and to evaluate the toxicology of the former. Methods: To evaluate cetuximab’s biosimilar APZ001, Crl:CD1(ICR) (CD-1) mice and Macaca fascicularis (cynomolgus monkey) were chosen for the studies on acute toxicity, chronic toxicity, pharmacokinetics in chronic toxicity and immunogenicity toxicity. The study also compared the pharmacokinetic parameters of APZ001 with those of cetuximab upon single and multiple drug administrations in cynomolgus monkeys. Results: Pharmacokinetic parameters including maximum concentration (C max ) and time to attain maximum drug concentration (T max ), clearance rate and apparent volume of distribution of APZ001 were compared with those of cetuximab in both single and multiple administration studies. Difference of pharmacokinetics from weekly administration of APZ001 and cetuximab in cynomolgus monkeys was insignificant (p > 0.05), with relative bioavailability of 116.9 %. Both APZ001-treated and cetuximabtreated CD-1 mice showed the same level of food intake and body weight. Hematological and serological data were similar from APZ001 antibody and cetuximab treatments, so were the acute and chronic toxicity. Weekly transfusion of APZ001 did not alter its pharmacokinetic parameters. The administered drug was hardly detected in the serum in the 31st and 37th week of recovery; no accumulation of drug was observed upon withdrawal. Conclusion: APZ001 has extremely similar characteristics as cetuximab in terms of pharmacokinetics and toxicity. Keywords: Cetuximab, Pharmacokinetics, Acute toxicity, Chronic toxicity, Immunogenicity, Biosimilar

Evaluation of pharmacokinetics and toxicology of biosimilar APZ001 antibody in <i>Macaca cynomolgus</i>