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

• Published in: Pharmacology research & perspectives Vol. 11; no. 2; pp. e01070 - n/a
• Main Authors: Schwabe, C., Cole, A., Espigares‐Correa, A., Beydon, M. E., Florez‐Igual, A., Queiruga‐Parada, J.
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.04.2023; John Wiley and Sons Inc; Wiley
• Subjects: Administration, Intravenous; Antibodies; bevacizumab; Bevacizumab - adverse effects; Bevacizumab - pharmacokinetics; Bioequivalence; Biological products; biosimilar; Biosimilar Pharmaceuticals; Blood & organ donations; clinical trial; Clinical trials; Double-Blind Method; Double-blind studies; Drug dosages; Electrocardiography; Humans; Male; Manufacturing; MB02; Medical laboratories; Monoclonal antibodies; Original; Pharmacokinetics; Pharmacology; Phlebotomy; Proteins; safety; Schedules; Software; Therapeutic Equivalency; Vascular endothelial growth factor; Vital signs; United States > US; clinical trial; bevacizumab; pharmacokinetics; MB02; safety; biosimilar

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 ra...