Celltrion receives approval for Mabthera biosimilar in EU

December 26, 2016 10:14 AM

Celltrion has received the CHMP approval for rituximab biosimilar, Truxima. The product is a biosimilar to Roche’s Mabthera and this is an important step for the company, after receiving the first approval in South Korea last month.

The CHMP (Committee for Medicinal Products for Human Use) adopted the positive opinion on 15th of December and recommended the granting of a marketing authorisation for the medicinal product Truxima, intended for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Mabthera, which is known as Rituxan in United States, was approved on 2 June 1998 in EU. Now the biosimilar version, Truxima will have the full indications of Mabthera and will be available as a 500 mg concentrate for solution for infusion.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


Source: EMA


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