Pharmacokinetics, safety, tolerability, and immunogenicity of FKB238, a new biosimilar of bevacizumab, in healthy participants

Objective: To compare the and immunogenicity of single intravenous doses of FKB238, a proposed biosimilar of approved and United States (US)-licensed bevacizumab in healthy participants. Materials and methods: In a randomized, doubleblind, parallel-group study, 99 healthy men received 5 mg of FKB238, EU-bevacizumab, or US-bevacizumab in a 1 : 1 : 1 ratio by signs, electrocardiogram, and safety tests of blood and urine were assessed before and up to 99 days after treatment. Results: The 90% confidence interval for the ratios of the primary (area under the curve ((AUC)0???t and AUC0???inf) and secondary (maximum concentration (Cmax) and elimination half-life (T1/2)) geometric mean PK parameters were entirely within the acceptance range for bioequivalence of 0.80 ??? 1.25 for all 3 pairwise comparisons by analysis of covariance, with baseline characteristics of age and body weight as covariates. FKB238 was well tolerated in healthy participants, and antidrug antibody (ADA) incidence was low and similar in all treatment groups. Conclusion: The study demonstrated the PK similarity of FKB238 to both EU-bevacizumab and USbevacizumab after a single intravenous infusion. FKB238 was well tolerated in healthy