Exposure-response analysis using time-to-event data for bevacizumab biosimilar SB8 and the reference bevacizumab.

This analysis aimed to characterize the exposure-response relationship of bevacizumab in non-small-cell lung cancer (NSCLC) and evaluate the efficacy of SB8, a bevacizumab biosimilar, and Avastin, the reference bevacizumab sourced from the European Union (EU), based on the exposure reported in a comparative phase III efficacy and safety study (EudraCT, 2015-004026-34; NCT02754882). The overall survival (OS) and progression-free survival (PFS) data from 224 patients with steady-state trough concentrations (C) were analyzed. A parametric time-to-event (TTE) model was developed using NONMEM, and the effects of treatments (SB8 and bevacizumab-EU) and patient demographic and clinical covariates on OS and PFS were evaluated.

Safety and Effectiveness of Trastuzumab Biosimilar SB3 in Korean Patients, a Post-Marketing Surveillance Study.

Introduction: SB3 is a trastuzumab biosimilar approved in Australia, Brazil, Canada, the European Union, the Republic of Korea, Switzerland, and the USA. This real-world study evaluated safety and effectiveness of SB3 as part of the Korean post approval safety management system.

Methods: This post-marketing surveillance in Korea included patients in line with approved indications, i.