Pharmacokinetics and safety of BCD-022, trastuzumab biosimilar candidate, compared to Herceptin in patients.

e11576 Background: BCD-022 is a trastuzumab biosimilar candidate manufactured by CJSC BIOCAD, Russia. Full spectrum of physicochemical and preclinical studies showed equivalence of BCD-022 to innovator drug trastuzumab. Methods: 46 patients with HER2(+) mBC were enrolled in the study. Patients were randomly assigned into 2 groups at a ratio of 1:1 to receive BCD-022 or trastuzumab (a single loading dose 8 mg/kg a maintenance dose 6 mg/kg) with paclitaxel (175 mg/m2) every 3 weeks. The primary endpoint was AUC(0-504), the secondary endpoints included Cmax, T1/2 и Tmax. Trastuzumab serum concentrations were evaluated immediately before the first infusion and after 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h. Results: PK analysis demonstrated that 90% CI for ratio of geometric means of AUC(0-504) of trastuzumab after single BCD-022 and trastuzumab administration was 80.42–120.87%, for ratio of Cmax– 83.69–123.05%. These ranges were within pre-specified PK equivalence criteria of 80–125 % accor...