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Pivotal clinical trials for rituximab biosimilars Posted 30/10/2015

Biosimilars of Roche’s MabThera/Rituxan (rituximab), a chimeric monoclonal antibody are currently under development.

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.

Pivotal trials for candidate rituximab biosimilars being carried out typically include two studies of the response rate with some progression-free survival data in two different indications. The trials take 24–48 months and are tougher trials to recruit and execute than anti-tumour necrosis factor (TNF) trials [1], see Table 1.

Table 1: Pivotal clinical trials for candidate rituximab biosimilars

The originator product, Roche’s Avastin (bevacizumab), was approved by the US Food and Drug Administration in February 2004 and by the European Medicines Agency in January 2005. The patents on Avastin are set to expire in Europe in January 2022 and in the US in July 2019 [2]. Avastin had worldwide sales of US$7.4 billion in 2014, making it a lucrative target for biosimilars manufacturers.

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1.  Gal R. Biosimilars: at the inflection point. 13th EGA-European Biosimilars Group Conference; 23–24 April 2015; London, UK.
2.  GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

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