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: SB4 - Enbrel® (etanercept) biosimilar candidate
Action
mechanism: biosimilar/TNF alpha inhibitor.
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 studies of SB4, an investigational biosimilar of Enbrel® (etanercept) met their 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 these studies, SB4demonstrated a safety profile equivalent to the originator medicines. These results will be presented for the first time at the European League Against Rheumatism (EULAR) 16th annual meeting in Rome, June 10-13. SB4 Phase 3 data presented at EULAR Samsung Bioepis conducted a randomized, double-blind, parallel group, multicenter study evaluating the efficacy, safety, pharmacokinetics and immunogenicity of SB4 biosimilar etanercept compared to originator Enbrel®, in adult patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. In the SB4 biosimilar etanercept study, 596 patients were randomized at 70 sites in 10 countries. In this study, SB4 was shown to be equivalent to Enbrel in terms of ACR20 response rate at week 24 of treatment in the per-protocol set: 78.1 percent (193/247) in the SB4 arm vs. 80.3 percent (188/234) in the Enbrel arm. The adjusted rate difference was −2.22 percent (95 percent confidence interval, −9.41 percent to 4.98 percent), which was within the pre-defined margin (−15 percent, 15 percent). Samsung Bioepis also presented results of a randomized, single-blind, three-arm, parallel group Phase 1 study of SB4 demonstrating the pharmacokinetic (PK) equivalence of its biosimilar candidate to its respective originator product sourced in the U.S. and in the EU. The study also demonstrated the PK equivalence of the U.S. and EU sourced originator products. An equivalent safety profile to the originator product was demonstrated for each of the three biosimilar products in each of the three studies.
