Purpose: To compare the pharmacokinetics of APZ001 antibody with those of cetuximab (Erbitux®)\nand to evaluate the toxicology of the former.\nMethods: To evaluate cetuximabâ??s biosimilar APZ001, Crl:CD1(ICR) (CD-1) mice and Macaca\nfascicularis (cynomolgus monkey) were chosen for the studies on acute toxicity, chronic toxicity,\npharmacokinetics in chronic toxicity and immunogenicity toxicity. The study also compared the\npharmacokinetic parameters of APZ001 with those of cetuximab upon single and multiple drug\nadministrations in cynomolgus monkeys.\nResults: Pharmacokinetic parameters including maximum concentration (Cmax) and time to attain\nmaximum drug concentration (Tmax), clearance rate and apparent volume of distribution of APZ001 were\ncompared with those of cetuximab in both single and multiple administration studies. Difference of\npharmacokinetics from weekly administration of APZ001 and cetuximab in cynomolgus monkeys was\ninsignificant (p > 0.05), with relative bioavailability of 116.9 %. Both APZ001-treated and cetuximabtreated\nCD-1 mice showed the same level of food intake and body weight. Hematological and\nserological data were similar from APZ001 antibody and cetuximab treatments, so were the acute and\nchronic toxicity. Weekly transfusion of APZ001 did not alter its pharmacokinetic parameters. The\nadministered drug was hardly detected in the serum in the 31st and 37th week of recovery; no\naccumulation of drug was observed upon withdrawal.\nConclusion: APZ001 has extremely similar characteristics as cetuximab in terms of pharmacokinetics\nand toxicity.
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