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Biosimilars of basiliximab Posted 26/08/2016

Basiliximab is a chimeric mouse-human monoclonal antibody to the α chain (CD25) of the IL-2 receptor of T cells. It is an immunosuppresant agent used to prevent immediate transplant rejection in people who are receiving kidney transplants, in combination with other agents.

The originator product, Novartis’s Simulect (basiliximab), was approved by the US Food and Drug Administration (FDA) on 12 May 1998 and by the European Medicines Agency (EMA) on 9 October 1998 [1]. Simulect had worldwide sales of US$1.1 billion in 2015.

The patents on Simulect expired in Canada in March 2011 and in Europe in April 2013 [1]. To our knowledge, there is only one basiliximab non-originator biological* currently in development, see Table 1.

Table 1: Non-originator biological* of basiliximab in development

Company name, Country

Product name

Stage of development

Sorrento Therapeutics/MabTech, USA/China*


Working on copy biological in China [2]

*See editor’s comment

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) and partner, MabTech, are working on STI-003 in China, a copy biological for basiliximab (Simulect) [2].

Editor’s comment
It should be noted that ‘copy biologicals’ approved in China might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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1. Derbyshire M. Patent expiry dates for best-selling biologicals, Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for omalizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 26]. Available from: www.gabionline.net/Biosimilars/News/Positive-phase-III-results-for-omalizumab-copy-biological

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Source: EMA

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