Coherus BioSciences, Inc. and Baxalta Incorporated announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study. This ongoing study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients with moderate-to-severe rheumatoid arthritis that is inadequately controlled with methotrexate alone. The study continues as planned until Week 52.

The primary efficacy endpoint was the proportion of subjects achieving ACR20 (20% improvement according to the American College of Rheumatology criteria) at Week 24. The primary endpoint was within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel. There were no clinically meaningful differences in the safety and immunogenicity profiles of the two products.

CHS-0214 was evaluated in two comprehensive single-dose, cross-over pharmacokinetic /bioequivalence (PK /BE) studies in healthy volunteers. In both trials, CHS-0214 demonstrated PK similarity to Enbrel® based on pre-specified pharmacokinetic criteria. The safety profiles of CHS-0214 and Enbrel® were similar in these studies.

CHS-0214 was also evaluated in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study in patients with moderate-to-severe chronic plaque psoriasis. 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.