A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin® (EU and US) in healthy male subjects

• Published in: British journal of clinical pharmacology Vol. 84; no. 10; pp. 2352 - 2364
• Main Authors: Wynne, Chris, Schwabe, Christian, Batra, Sonica Sachdeva, Lopez‐Lazaro, Luis, Kankanwadi, Suresh
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 01.10.2018
• Subjects: Adult; Antineoplastic Agents, Immunological - administration & dosage; Antineoplastic Agents, Immunological - adverse effects; Antineoplastic Agents, Immunological - pharmacokinetics; Area Under Curve; Bevacizumab - administration & dosage; Bevacizumab - adverse effects; Bevacizumab - pharmacokinetics; bioequivalence; Biosimilar Pharmaceuticals - administration & dosage; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - pharmacokinetics; Double-Blind Method; Follow-Up Studies; Healthy Volunteers; Humans; Infusions, Intravenous; Male; Neoplasms - drug therapy; Neoplasms - immunology; oncology; Original; pharmacokinetics; Phase I; Therapeutic Equivalency; Vascular Endothelial Growth Factor A - antagonists & inhibitors; Vascular Endothelial Growth Factor A - immunology; Young Adult; pharmacokinetics; Phase I; bioequivalence; oncology

Aim The aim of this study was to compare the pharmacokinetics (PK) of DRL_BZ with that of EU‐approved (reference medicinal product; RMP) and US‐licensed (reference product; RP) bevacizumab (Avastin®) in healthy male subjects. Methods In this double‐blind, parallel‐group, Phase 1 study (BZ‐01‐001), m...