Coherus: Second Pivotal Study On CHS-0214 Meets Primary Endpoint - Quick Facts

(RTTNews) - Coherus BioSciences, Inc. (CHRS) and Baxalta Inc. (BXLT) 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. The 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.

Coherus reported that there were no clinically meaningful differences in the safety and immunogenicity profiles of the two products.

Denny Lanfear, President and CEO of Coherus, said: "The second pivotal clinical study comparing CHS-0214 to Enbrel has met its primary endpoint. We look forward to advancing this product to registration in various territories in 2016."