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.
Coherus chief medical officer Barbara Finck said: "Rheumatoid arthritis that remains active despite methotrexate treatment has a significant impact on a patient’s health and quality of life.
"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.
Coherus president and CEO Denny Lanfear said: "We are pleased that this 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."
Baxalta executive vice president and president of biosimilars Dagmar Rosa-Björkeson said: "Etanercept transformed the treatment for many with moderate to severe rheumatoid arthritis and other inflammatory conditions, significantly improving patients’ quality of life.
"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."
About CHS-0214, a proposed biosimilar of Enbrel (etanercept)
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.