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Celltrion's Truxima First Biosimilar MAB In Oncology To Win EU Approval

 
• By Sten Stovall

Celltrion's version of Roche’s MabThera (rituximab), Truxima, has become the first biosimilar anticancer to win marketing authorization in Europe.

European Union

A medical milestone was reached Feb. 22 when Celltrion Inc.’s Truxima (rituximab), a version of Roche’s MabThera, became the first biosimilar to win marketing approval in an oncology indication in Europe, leading a group of novel anticancer bio-copies poised to enter the European market.

Truxima received its EU approval two months after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended it be given marketing authorization for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis

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