Celltrion submits rituximab biosimilar application to EMA

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Celltrion submits rituximab biosimilar application to EMA

Biosimilars/News | Posted 20/11/2015 0 Post your comment

South Korean biotechnology company Celltrion has, according to Business Korea, submitted a second biosimilar application to the European Medicines Agency (EMA).

The application for approval of Celltrion’s rituximab biosimilar CT-P10 was submitted to EMA on 10 November 2015. This action makes Celltrion the first company in the world to submit an application for approval of a rituximab biosimilar.

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

There is unfortunately no information in what indications Celltrion is seeking approval. There is also no mention of what data were included in the submission.

The originator product, Roche’s MabThera/Rituxan (rituximab) had sales of CHF 5.7 billion (Euros 5.2 billion) in 2014. The patents on MabThera/Rituxan expire in the US in September 2016 and expired in Europe in February 2013 [1].

Celltrion’s infliximab biosimilar (Remsima) was approved by EMA in September 2013 [2] and the company filed its biosimilar application for CT-P13 (infliximab) in the US back in August 2014, claiming it to be the first monoclonal antibody application to be filed in the US [3]. Celltrion has also started a phase III clinical trial for its biosimilar trastuzumab candidate (CT-P6) [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion starts phase III biosimilar trastuzumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20}. Available from: www.gabionline.net/Biosimilars/News/Celltrion-starts-phase-III-biosimilar-trastuzumab-trial

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Source: Business Korea