Teva And Celltrion Say FDA Accepts BLA For Proposed Biosimilar To Rituxan

(RTTNews) - Celltrion Inc., a global biopharmaceutical company, and Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) for CT-P10, a proposed Monoclonal Antibody or mAb biosimilar to Rituxan (rituximab), which is used to treat patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia or CLL, rheumatoid arthritis or RA, granulomatosis with polyangiitis and microscopic polyangiitis.

The BLA for CT-P10 includes data for CT-P10 and reference rituximab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK). These trials were conducted in over 600 patients and include up to 104 weeks of data. CT-P10 was approved by the European Commission in February 20172 and has launched in the U.K., Germany, Netherlands, Spain and the Republic of Korea.