Posted by Michael Wonder on 30 Jun 2017
Celltrion and Teva announce U.S. FDA acceptance of biologics license application for proposed biosimilar to Rituxan (rituximab)
29 June 2017 - Celltrion and Teva Pharmaceutical Industries today announced that the U.S. FDA has accepted for review the biologics license application for CT-P10, a proposed monoclonal antibody biosimilar to Rituxan (rituximab), which is used to treat patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
The application for CT-P10 includes data for CT-P10 and reference rituximab in terms of efficacy, safety, immunogenicity, pharmacodynamics and pharmacokinetics. 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.
