Pharmacokinetics and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin in patients.

e13500 Background: BCD-021 is a bevacizumab biosimilar candidate manufactured by CJSC BIOCAD, Russia. Full spectrum of physicochemical and preclinical studies showed equivalence of BCD-021 to innovator drug Avastin. Methods: 28 patients with advanced non-squamous NSCLC (stage IIIb/IV) were enrolled in the study. Patients were randomly assigned into 2 groups at a ratio of 1:1 to receive BCD-021 or Avastin at a dose of 15 mg/kg in combination with paclitaxel (175 mg/m2) and carboplatin (AUC 6 mg/ml×min) every 3 weeks. The primary endpoint was AUC(0-504), the secondary endpoints included Cmax, T1/2 e Tmax. Bevacizumab 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: Pharmacokinetic (PK) analysis demonstrated that 90% CI for ratio of geometric means of AUC(0-504) of bevacizumab after single BCD-021 and Avastin administration was 80.01–118.28%. This range was within pre-specified PK equivalence criteria of 8...