Phase III trial shows SB2 (infliximab biosimilar) has similar safety profile to Remicade in rheumatoid arthritis- Samsung Bioepis
Samsung Bioepis announced that SB2 (infliximab biosimilar) sustained comparable safety profile to Remicade (infliximab) in a 54-week randomised, double-blind, phase III study comparing SB2 in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. The 54-week SB2 study, which randomised 584 patients across 73 sites in 11 countries, showed an ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the Remicade arm, fully supporting the 30-week study results of 64.1% and 66.0%, respectively. The latest results for SB2 will be presented at the upcoming 2015 Annual Meeting of the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals.
SB2 was submitted to the European Medicines Agency (EMA) in March 2015. It faces a crowded marketplace: there are currently around 30 other biosimilar drugs in studies for rheumatoid arthritis, of which the majority are in phase III trials.
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