FDA accepts for review the BLA for CT P10 biosimilar to Rituxan (rituximab).- Teva + Celltrion

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

CT P10 is is expected to be the first rituximab biosimilar in the US. The rituximab patent in the US expired in September 2016. The BLA 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 2017 and has launched in the U.K., Germany, Netherlands, Spain and the Republic of Korea. The BLA for CTP 10 has been accepted for filing by the FDA for standard review, with FDA Regulatory Action expected during the first quarter of 2018. Teva Pharmaceutical Industries Ltd. has rights from Celltrion to sell CT P10 in the US and Canada.