CHS-0214 (Coherus BioSciences/Baxalta Inc.), a proposed biosimilar of etanercept (Enbrel, Amgen), has met its primary endpoint in a phase 3, double-blind, randomized, controlled clinical trial. This ongoing, 52-week study is evaluating the efficacy and safety of CHS-0214 compared with etanercept in patients with moderate-to-severe rheumatoid arthritis (RA) that has been inadequately controlled with methotrexate alone.
The study’s primary efficacy endpoint was the proportion of subjects achieving a 20% improvement according to the American College of Rheumatology criteria (ACR20) at week 24. This endpoint was within the prespecified margins for demonstrating the equivalence of CHS-0214 compared with etanercept. There were no clinically meaningful differences in the safety and immunogenicity profiles of the two products.
CHS-0214 was previously evaluated in two single-dose, crossover pharmacokinetic (PK)/bioequivalence studies in healthy volunteers. In both trials, CHS-0214 demonstrated a PK profile similar to that of etanercept based on prespecified PK criteria. The safety profiles of CHS-0214 and etanercept were similar in these studies.
CHS-0214 was also evaluated in a confirmatory, double-blind, randomized, controlled, phase 3 study in patients with moderate-to-severe chronic plaque psoriasis. At week 12, the co-primary endpoints –– the mean percent change in the Psoriasis Area Severity Index (PASI) from baseline and the proportion of subjects achieving 75% improvement in the PASI from baseline —were within the prespecified margins for demonstrating the equivalence of CHS-0214 compared with etanercept. There were no clinically meaningful differences in the safety profiles of the two products.
Source: Baxalta; January 11, 2016.