High Bio-Physico-Chemical Comparability of Vmb-015, A Vedolizumab Biosimilar, With the Originator Drug Entyvio®

Vedolizumab is a humanized igg-1 therapeutic monoclonal antibody (mab) produced recombinantly in chinese hamster ovary (cho) cells, which is marketed under the trade name entyvio® by takeda pharmaceuticals# it was approved by the us fda for treatment of ulcerative colitis and crohn's disease in 2014# vedolizumab selectively targets α4β7 integrin expressed on lymphocyte cell surfaces, blocking its interaction with madcam-1, and thus rendering specific modulation of the inflammatory pathways in the gastrointestinal tract# this article is the first report on development of a vedolizumab biosimilar (vmb-015), carried out by persisgen par co# the nonclinical comparative analytical assessment of vmb-015 included peptide mapping, glycan mapping, charge variants analysis, purity analysis, bioactivity analysis, and analysis of drug osmolality, coloration, clarity and opalescence# the results unanimously demonstrated the high degree of vmb-015 comparability with entyvio®, which confirmed the high quality of manufacturing process development in persisgen par co# biopharmaceutical developer#