EC approval for first cancer biosimilar Truxima

Biosimilars/News | Posted 03/03/2017 post-comment0 Post your comment

South Korean biotechnology company Celltrion announced on 22 February 2017 that it had received European Commission (EC) approval for the marketing authorization for its rituximab biosimilar Truxima.

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The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 16 December 2016 [1].

Truxima (CT P10) has been approved for all the indications of the reference biological, Roche’s MabThera/Rituxan (rituximab), in the European Union (EU). These include treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

The approval was based on the totality of evidence submitted to EMA, which according to Celltrion showed ‘compelling similarity between Truxima and reference rituximab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK) in patients with rheumatoid arthritis and advanced follicular lymphoma, a type of non-Hodgkin’s lymphoma’. The trials were conducted in more than 600 patients and include data up to 104 weeks.

Celltrion estimates that the EU could save around Euros 570 million over the first three years after introduction of Truxima. This they base on an assumption that the price of Truxima is 70% compared to MabThera/Rituxan and the market share of Truxima is 30% (first year), 40% (second year) and 50% (third year). This they say ‘equates to 49,000 new rheumatoid arthritis, non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia patients’ who could be receiving life-changing treatment’.

Truxima is the first biosimilar monoclonal antibody approved in an oncology indication worldwide and is 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 was approved in September 2013 [2].

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 Administration by early 2017 [3]. In order to facilitate the marketing of Truxima in the US and Canada Celltrion made a deal with Teva Pharmaceutical Industries in October 2016. The collaboration also includes its candidate trastuzumab biosimilar, Herzuma (CT-P6) [4].

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1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for rituximab biosimilar Truxima []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 4]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 4]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in South Korea []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 4]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. Teva and Celltrion to partner on biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 4]. Available from:

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Source: Celltrion

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