One year results for SB4 (etanercept biosimilar) are comparable to Enbrel in rheumatoid arthritis- Samsung Bioepis

Samsung Bioepis announced that SB4 (etanercept biosimilar) sustained comparable safety profile with Enbrel (etanercept) in patients with moderate to severe rheumatoid arthritis in a 52-week clinical study. The 52-week SB4 study, which randomised 596 patients across 70 sites in 10 countries, showed ACR20 response rate of 80.8% in the SB4 arm versus 81.5% in the Enbrel arm, fully supporting the 24-week study results of 78.1% and 80.3%, respectively. The latest results will be presented at the upcoming 2015 Annual Meeting of the American College of Rheumatology and the Association for Rheumatology Health Professionals.

Comment: Samsung Bioepis has been developing six biosimilar molecules and expects to launch those products starting in 2016. Marketing authorisation applications for SB2 and SB4 have been submitted to health authorities in the EU and South Korea. Additional biosimilars in development by the South Korean company, are SB9 – an insulin glargine biosimilar candidate, which is currently in phase III clinical studies, SB3 – an investigational biosimilar of Herceptin (trastuzumab), also in phase III, and SB8 – an investigational biosimilar of Avastin (bevacizumab), which is currently in phase I clinical studies.