Date: 2015-11-09
Type of information: Results
phase: 3
Announcement: results
Company: Coherus Biosciences (USA - CA) Baxalta (USA - IL)
Product: CHS-0214 (investigational etanercept biosimilar)
Action
mechanism: biosimilar/TNF alpha inhibitor. CHS-0214/Etanercept, is an anti-tumor necrosis factor (TNF) agent. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases. Coherus and Baxalta initiated a collaboration to develop and commercialize CHS-0214 in September of 2013.
Disease: plaque psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country: Australia, Canada, Germany, Israel, Poland, South Africa, UK, USA
Trial
details: This double-blind, randomized, parallel-group, active-control study compares the efficacy and safety of CHS-0214 versus Enbrel® in subjects with chronic plaque psoriasis (RaPsOdy). This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who have not yet received any biologic therapy for any indication (other than insulin or hormones). (NCT02134210)
Latest
news: * On November 09, 2015, Coherus BioSciences and Baxalta announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study. This on-going 52-week study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel® in patients with moderate-to-severe chronic plaque psoriasis. The efficacy endpoints were based on a Week 12 assessment of Psoriasis Activity Severity Index (PASI) scores. At Week 12, the primary endpoints, the mean percent change in PASI from baseline and the proportion of subjects achieving 75% improvement in PASI from baseline, were within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel®. There were no clinically meaningful differences in the safety profiles of the products. The study continues as planned until Week 52. The psoriasis study is one of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the second Phase 3 study in patients with rheumatoid arthritis are expected in the first quarter of 2016.
