Rituximab biosimilar CT-P10 for the treatment of rheumatoid arthritis.

Introduction: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by long-standing inflammation in multiple joints. Rituximab, a monoclonal antibody, which binds to CD20, is effective in suppressing disease activity and preventing joint damage in RA. CT-P10 was developed as a biosimilar of rituximab and approved for use to treat hematologic malignancies and immune diseases including RA. Area covered: This article describes the need for this biosimilar and summarizes the non-clinical studies verifying the physicochemical and biologic similarities and the clinical studies confirming the clinical similarity of CT-P10 to rituximab in patients with RA. Expert opinion: CT-P10 had been evaluated and proven the efficacy and safety in RA in Phase I and III randomized controlled trial with extension studies including a switching regimen. Therefore, CT-P10 is recommended in the treatment of RA.