According to a recent paper in The Lancet, a new phase 3 study shows that CT-P13, Celltrion and Pfizer’s infliximab biosimilar, is non-inferior to the reference biologic, REMICADE, for the treatment of Crohn’s disease. CT-P13 was approved by the European Commission under the trade name Remsima® in September 2013, and by the US FDA under the trade name Inflectra® in April 2016. CT-P13’s approval was based on proof of biosimilarity compared to the reference infliximab in clinical studies involving the treatment of ankylosing spondylitis and rheumatoid arthritis, but it had not been directly compared with the reference infliximab for the treatment of Crohn’s disease. According to the Lancet publication, PLANETCD, a phase 3 study involving 220 patients with Crohn’s disease across 16 countries, showed comparable efficacy and safety profiles between CT-P13 and the reference infliximab.
A Celltrion press release about the publication quoted Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare, as saying: “The PLANETCD study is the first investigation of the therapeutic efficacy of an infliximab biosimilar powered to show non-inferiority to reference infliximab in inflammatory bowel disease. We at Celltrion Healthcare are proud to be the company leading the way in the biosimilar space as well as witness the growing recognition attributed to our products due to their high quality and cost effectiveness. This PLANETCD study published in The Lancet, together with the evidence from the influential NOR-SWITCH study, which was performed across multiple indications, support the equivalence between CT-P13 and reference infliximab.”