A randomized, double‐blind, single‐dose study to assess bioequivalence of MB02 biosimilar after manufacturing iteration and reference bevacizumab

ABSTRACT: Abstract To investigate and compare the pharmacokinetic (PK) profiles of MB02 products, before and after optimizing the manufacturing process, and reference bevacizumab to establish bioequivalence between them. In this randomized, double‐blind, single dose, parallel study, 114 healthy male volunteers were randomized 1:1:1 to receive a 1 mg/kg intravenous dose of MB02‐SP, MB02‐DM, or US‐bevacizumab. The follow‐up period was 100 days. PK similarity between them was determined using the standard bioequivalence criteria (0.80–1.25) for the area under the serum concentration–time curve from time 0 extrapolated to infinity and the maximum observed serum concentration. Study results showed that the PK profiles of bevacizumab were similar. Statistical analysis demonstrated that for each pairwise c

SUBMITTER: Schwabe C 

PROVIDER: S-EPMC10011608 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature