ARTICLE | Clinical News

Benepali etanercept less immunogenic than reference product in Phase III

February 2, 2018 8:17 PM UTC

A research letter published in the British Journal of Dermatology reported that Benepali etanercept (SB4), a biosimilar of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN), was less immunogenic than its reference product in a Phase III trial in 596 patients with moderate to severe rheumatoid arthritis. Specifically, anti-drug antibodies were detected in 1% of patients who received Benepali vs. 13.1% of patients who received Enbrel (p<0.001). Additionally, injection-site reactions were reported in 3.7% of patients who received Benepali vs. 17.5% of patients who received Enbrel.

Previously reported data from the double-blind, European trial showing that Benepali met the primary endpoint of equivalence to Enbrel as measured by the proportion of patients achieving a 20% improvement in the American College of Rheumatology criteria (ACR20) at week 24 (see BioCentury, June 15, 2015 & June 20, 2016)...