A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab

• Published in: Journal of cancer research and clinical oncology Vol. 148; no. 2; pp. 487 - 496
• Main Authors: Hummel, Matthew, Bosje, Tjerk, Shaw, Andrew, Liu, Mark Shiyao, Barve, Abhijit, Kothekar, Mudgal, Socinski, Mark A., Waller, Cornelius F.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.02.2022; Springer Nature B.V
• Subjects: Adolescent; Adult; Angiogenesis; Bevacizumab; Bevacizumab - chemistry; Bevacizumab - pharmacokinetics; Bioequivalence; Biological products; Biosimilar Pharmaceuticals - chemistry; Biosimilar Pharmaceuticals - pharmacokinetics; Cancer Research; Clinical trials; Double-Blind Method; Drug Compounding - methods; Drug Compounding - standards; Europe; Healthy Volunteers; Hematology; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Monoclonal antibodies; Netherlands; Oncology; Original Article – Clinical Oncology; Original – Clinical Oncology; Pharmacokinetics; Safety; Targeted cancer therapy; Therapeutic Equivalency; United States; Vascular endothelial growth factor; Young Adult; United States; Netherlands; Europe; United States > US; Monoclonal antibody; Phase 1; Bioequivalence; Pharmacokinetics; Cancer

Purpose Bevacizumab is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor-specific angiogenesis in some cancers. MYL-1402O is a proposed bevacizumab biosimilar. Methods The primary objective of this single-center, randomized, double-blind, three-arm, paralle...