Date: 2016-03-24
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Samsung Bioepis (Republic of Korea)
Product: SB8 (biosimilar version of bevacizumab - Avastin®)
Action
mechanism: monoclonal antibody/biosimilar. Bevacizumab is a humanized antibody to vascular endothelial growth factor (VEGF). It binds VEGF and prevents the interaction of VEGF to its receptors on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: Belarus, Georgia, Germany, Hungary, Republic of Korea, Poland, Romania, Russia, Serbia, Spain, Taiwan, Ukraine
Trial
details: This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer. (NCT02754882)
Latest
news: * On March 24, 2016, Samsung Bioepis has started a phase III clinical trial for SB8, a biosimilar version of Avastin® (bevacizumab). The trial will be carried out in 678 patients. The study is designed to compare the efficacy, safety, pharmacokinetics and immunogenicity between SB8 (proposed bevacizumab biosimilar) and Avastin® in subjects with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
