Celltrion’s Truxima (CT-P10, rituximab), a biosimilar to Rituxan® received approval from the European Commission on February 22, 2017. Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Truximab for approval on December 15, 2016. Truxima is the first biosimilar product for the treatment of cancer that has been approved in Europe. Truxima was approved in South Korea in November 2016 and it has been reported that Celltrion plans to submit an application for rituximab to the FDA in early 2017.
Celltrion’s Truxima (rituximab) Approved in Europe
