You are here

Etanercept (Enbrel) Biosimilar Meets Goal in Late-Stage Study

Product shows clinical equivalency in RA patients

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.

More Headlines

Liver Fluke Infestation Affects Almost 2.5 Million People Globally
Policy Could Be Life-Changing for People With Spinal Cord Injury
Test Determines Severity of Pain, Helps Physicians Select Best Options
Intratumoral Injection Stimulates Immune Activation
Diabetes and Cancer Patients Could Soon Avoid Injections
Early Cancer Development May Begin in Just 30 Minutes