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New Version of Bevacizumab Biosimilar Found Bioequivalent to Referent
The biosimilars MB02-SP and MB02-DM were found to be bioequivalent to referent bevacizumab, according to a randomized, double-blind, single-dose study.
Bevacizumab is an anti-VEGF monoclonal antibody, with MB02 as a biosimilar approved in Europe in 2021 and the United States in 2022. MB02-SP is a result of the standard process, while MB02-DM is a result of the optimized drug substance manufacturing process. Through comparative assessment, it was found that MB02-DM was highly comparable to MB02-SP. This current trial was conducted to compare the pharmacokinetic profile of MB02-SP, MB02-DM, and US-bevacizumab, establish bioequivalence among the 3 treatments, and fulfill criteria for a pharmacokinetic bridging study.
In this phase 1 study, 114 healthy, male volunteers were randomized on a 1-to-1-to-1 basis, to receive MB02-SP (n = 37), MB02-DM (n = 39), or US-bevacizumab (n = 38). The primary objective of the study was to investigate and compare the pharmacokinetic profiles of MB02-SP, MB02-DM, and US-bevacizumab to establish bioequivalence among them all. Secondary objectives included safety and immunogenicity.
The pharmacokinetic profiles of all three drugs were similar, following a single 90-minute IV infusion of 1 mg/kg of each. There were 159 treatment-emergent adverse events reported, 42 in the MB02-SP arm, 58 in the MB02-DM, and 59 in the bevacizumab arm. None of the adverse events were severe and there were no discontinuations due to adverse events or deaths on study. There were 27.2% of subjects who tested positive for antidrug antibodies at different times.
The study authors concluded, “this phase 1 clinical trial proves that MB02-DM is comparable to MB02-SP and that it is biosimilar to the reference product, supporting the conclusions drawn at analytical level.
Source:
Schwabe C, Cole A, Espigares-Correa A, et al. A randomized, double-blind, single-dose study to assess bioequivalence of MB02 biosimilar after manufacturing iteration and reference bevacizumab. Pharmacol Res Perspect. 2023;11(2): e01070. doi:10.1002/prp2.1070
