Phase III trial of CHS 0214 (etanercept biosimilar) meets endpoint in plaque psoriasis- Coherus BioSciences/Baxalta

Coherus BioSciences and Baxalta announced that CHS 0214 (etanercept biosimilar) met its primary endpoints in a confirmatory, double-blind, randomised, controlled, two-part Phase III 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 (PASI 75), 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.

Comment: The psoriasis study is one of two, large, Phase III confirmatory trials intended for inclusion in global marketing applications for CHS 0214. Results for the second Phase III study in patients with rheumatoid arthritis are expected in the first quarter of 2016.