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Samsung Bioepis' SB4 and SB2 Investigational Biosimilar Candidates Sustain Comparable Safety Profiles in One-Year Phase 3 Clinical Studies
PipelineReview.com (11/07/15)
Samsung Bioepis Co. reports that its SB4 etanercept and SB2 infliximab investigational biosimilar candidates showed comparable safety profiles in one-year clinical studies. In addition, the SB5 adalimumab investigational biosimilar candidate showed both equivalent efficacy and comparable safety in a 24-week, Phase III clinical study. The study results were presented at the 2015 Annual Meeting of the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals in San Francisco. The SB4 study, which included 596 patients in 10 countries, showed an ACR20 response rate of 80.8 percent in the SB4 arm, compared with 81.5 percent in the Enbrel arm. The SB2 study, which included 584 patients in 11 countries, showed an ACR20 response rate of 65.3 percent in the SB2 arm, compared with 69.2 percent in the Remicade arm. Meanwhile, the study of SB5--which involved 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy--found that the ACR20 response rate was 72.5 percent in the SB5 arm and 72.0 percent in the Humira arm. Researchers report that SB5's safety profile was also comparable to Humira.
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