ARTICLE | Clinical News
Amgen's biosimilar non-inferior to Remicade in Phase III for RA
July 27, 2018 3:39 PM UTC
Amgen Inc. (NASDAQ:AMGN) said 3 mg/kg ABP 710, a biosimilar of Remicade infliximab, was non-inferior to Remicade on the primary endpoint of the proportion of patients with a 20% improvement in American College of Rheumatology criteria (ACR20) at week 22 in a Phase III trial in 558 patients with moderate to severe rheumatoid arthritis. The prespecified equivalence margin was 15%. The overall safety and immunogenicity were comparable between treatment arms in the double-blind, international trial.
Amgen said it plans to submit regulatory applications for ABP 710, but declined to disclose details...
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