Markus R, et al. – The pharmacokinetic (PK) profiles of the proposed biosimilar ABP 215 with bevacizumab in healthy males were compared. The PK similarity of ABP 215 to both bevacizumab (US) and bevacizumab (EU), and of bevacizumab (US) to bevacizumab (EU) had been exhibited. Between treatments, safety and tolerability were comparable. In addition, no subject developed binding or neutralizing anti–drug anti–bodies.

Methods

• The clinicians randomized healthy subjects to receive ABP 215 (n = 68), bevacizumab (US) (n = 67), or bevacizumab (EU) (n = 67) 3 mg/kg intravenously in this randomized, single-blind, single-dose, three-arm, parallel-group study.
• Area under the serum concentration–time curve from time 0 extrapolated to infinity (AUCinf) and the maximum observed concentration (Cmax) were primary endpoints.
• Safety and immunogenicity were secondary endpoints.

Results

• Across the three groups, AUCinf and Cmax were similar.
• It was reported that geometric means ratio (GMR) for Cmaxand AUCinf, respectively, was 0.98 and 0.99 for ABP 215 versus bevacizumab (US); 1.03 and 0.96 for ABP 215 versus bevacizumab (EU); and 1.05 and 0.97 for bevacizumab (US) versus bevacizumab (EU).
• They observed that the 90% confidence intervals for the GMRs of AUCinf and Cmax were within the prespecified standard PK bioequivalence criteria of 0.80 to 1.25.
• 47.1, 32.8, and 61.2% were the incidence of adverse events (AEs) in the ABP 215, bevacizumab (US) and bevacizumab (EU) groups.
• The incidence and severity of AEs were comparable in the ABP 215 and bevacizumab groups, when analyzed by investigational site.
• No AEs were observed leading to study discontinuation.
• There were no binding or neutralizing anti-drug anti-bodies.