The objective of the study was to obtain information on the toxicity of biosimilar natalizumab (PB006) in comparison to the reference product Tysabri®. Cynomolgus monkeys (15 males and 15 females), three animals per sex and group were treated with either PB006 or the reference product Tysabri® at dose levels of 3 or 30 mg/kg body weight or placebo by intravenous infusion every other day for a period of 4 weeks. The study is also meant to facilitate ethics committee approval in specific countries for the planned confirmatory efficacy and safety study in patients. Based on study findings, it was concluded that there was no noteworthy difference between the animals treated with PB006 and the animals treated with Tysabri®. There were no noteworthy differences between PB006 and Tysabri® with respect to local tolerance, toxicity and pharmacokinetic profile in cynomolgus monkeys. In conclusion, obtained data are valid and suitable to support entry into clinical studies of PB006 in man.
Keywords: 4-week toxicity; PB006; Tysabri; cynomolgus; natalizumab; pharmacokinetics.