Celltrion and Teva announced today that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to Rituxan® (rituximab). Rituxan® (marketed as MabThera® in the EU) is approved for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. In the EU, CT-P10 was approved in February 2017 and is currently marketed as TruximaTM for the same indications as MabThera®.
Celltrion and Teva entered into an exclusive partnership to commercialize CT-P10 in the U.S. and Canada in October 2016.
Stay tuned to Big Molecule Watch for further developments.