EMA approval for rituximab biosimilar Truxima

Biosimilars/News | Posted 20/01/2017 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 16 December 2016 that it had recommended granting of marketing authorization for a rituximab biosimilar.


The rituximab biosimilar, which will be called Truxima (CT-P10), is produced by South Korean biotechnology company Celltrion. The drug is a biosimilar of Roche’s MabThera/Rituxan (rituximab).

EMA’s CHMP has recommended that Truxima be approved for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, i.e. for all the indications of the reference biological.

The drug marks Celltrion’s second biosimilar approval in Europe. The company’s first biosimilar to be approved by EMA was the infliximab biosimilar Remsima (CT‑P13), which gained European Union approval in September 2013 [1].

Truxima was also approved in South Korea in November 2016 and Celltrion has said that it plans to file Truxima for review by the US Food and Drug Agency by early 2017 [2].

The CHMP’s opinion will now be reviewed by the European Commission (EC). If approved, Truxima would be the first biosimilar rituximab to be approved by the EC. The biosimilar will be marketed and distributed in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and The Netherlands by Mundipharma. 

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1.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2.    GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-South-Korea

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Source: EMA, Mundipharma

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