EC approval for three rituximab biosimilars

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EC approval for three rituximab biosimilars

Biosimilars/News | Posted 08/09/2017 0 Post your comment

On 13 July 2017, three rituximab biosimilars, Blizima, Rituzena (previously Tuxella) and Ritemvia, received European Commission (EC) approval.

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.

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 19 May 2017 [1].

All three rituximab biosimilars are produced by South Korean biotechnology company Celltrion. The company also has an infliximab biosimilar approved in Europe, as well as another rituximab biosimilar. Remsima (infliximab) was approved in September 2013 and Truxima (rituximab) was approved in February 2017 [2].

The four-name strategy for rituximab is believed to be a tactic to generate greater total market share for its biosimilar and allow Celltrion to hand out distribution rights to several different companies. The company has already used a similar strategy for its infliximab biosimilar, which has two names – Inflectra and Remsima – with Hospira (now Pfizer) using Inflectra and Celltrion Remsima.

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for insulin and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-insulin-and-rituximab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: EMA