By Jonathan Kay
Arthritis & Rheumatology
Volume 68, Issue 5, pages 1049–1052, May 2016
Since the US Food and Drug Administration (FDA) first approved the anti–tumor necrosis factor (anti-TNF) monoclonal antibody infliximab in 1998 to treat patients with inflammatory bowel disease, targeted biologic therapies have revolutionized the treatment of inflammatory diseases. However, their high cost has limited access to these very effective agents for many patients. Thus, biosimilar agents are being developed so that these biopharmaceuticals can be made available at significantly lower prices. CT-P13, a biosimilar infliximab developed in South Korea by Celltrion, was the first biosimilar therapeutic monoclonal antibody approved by a regulatory agency, and it was approved by the US FDA on April 5, 2016. In this issue of Arthritis & Rheumatology, Kim and colleagues report on the use of CT-P13 in South Korea during the first 16 months after its introduction in November 2012 .