Date: 2015-06-10
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the European League Against Rheumatism Annual Congress (EULAR 2015)
Company: Merck&Co (USA - NJ) Samsung Biologics (Republic of Korea)
Product: SB2 - Remicade® (Infliximab) biosimilar candidate
Action
mechanism: infliximab biosimilar
Disease: moderate to severe rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On June 10, 2015, Merck&Co and Samsung Bioepis announced that pivotal Phase 3 clinical studiy of SB2, an investigational biosimilar of Remicade (infliximab), met its primary endpoints, demonstrating equivalence to the originator medicine in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy. The primary endpoint in the study was the American College of Rheumatology 20 percent response criteria (ACR20), at week 24 and at week 30 of treatment, respectively. In this study, SB2 demonstrated a safety profile equivalent to the originator medicine. These results will be presented for the first time at the European League Against Rheumatism (EULAR) 16th annual meeting in Rome, June 10-13. SB2 Phase 3 data presented at EULAR: Samsung Bioepis conducted two randomized, double-blind, parallel group, multicenter studies evaluating the efficacy, safety, pharmacokinetics and immunogenicity of SB4 biosimilar etanercept and SB2 biosimilar infliximab compared to originator Enbrel and Remicade, respectively, in adult patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Enbrel and Remicade are TNF inhibitors approved in the U.S. and many other countries for the treatment of rheumatoid arthritis and certain other indications. In the SB2 biosimilar infliximab study, 584 patients were randomized at 73 sites in 11 countries. In this study, SB2 was shown to be equivalent to Remicade in terms of ACR20 response rate at week 30 of treatment in the per-protocol set: 64.1 percent (148/231) in the SB2 arm vs. 66.0 percent (163/247) in the Remicade arm. The adjusted rate difference was −1.88 percent (95 percent confidence interval, −10.26 percent to 6.51 percent), which was within the pre-defined margin (−15 percent, 15 percent).
