Coherus and Baxalta announce etanercept biosimilar met primary endpoint in Phase 3 study

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.

“Rheumatoid arthritis that remains active despite methotrexate treatment has a significant impact on a patient’s health and quality of life,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “If approved, CHS-0214 has the potential to expand access and treatment options for patients with moderate-to-severe rheumatoid arthritis and other inflammatory diseases for which etanercept is indicated.”

This rheumatoid arthritis study is the second of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the first Phase 3 study in patients with chronic plaque psoriasis were released in November 2015 and showed that this first study also met its primary endpoints.

“We are pleased that this second pivotal clinical study comparing CHS-0214 to Enbrel has met its primary endpoint,” said Denny Lanfear, President and Chief Executive Officer of Coherus. “We look forward to advancing this product to registration in various territories in 2016.”

“Etanercept transformed the treatment for many with moderate-to-severe rheumatoid arthritis and other inflammatory conditions, significantly improving patients’ quality of life,” said Dagmar Rosa-Björkeson, Executive Vice President and President, Biosimilars of Baxalta. “This important clinical milestone, adding to previously-announced positive data in patients with chronic plaque psoriasis, brings us one step closer to expanding treatment options for patients.”