FDA issues complete response to filing of Truxima biosimilar for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.- Celltrion+Teva Pharma
Celltrion and Teva Pharmaceutical announced that the FDA has issued a complete response letter for Truxima (rituximab biosimilar), also called CT P10, after its application to treat patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis which was submitted in summer 2017. The letter is related to a warning in January that came from the regulator over issues at the company's manufacturing plant.
Comment: Patent expiry of MabThera occurred in the EU in November 2013 and in the US for Rituxan in September 2016.
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