Pivotal clinical trials for trastuzumab biosimilars

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Biosimilars of Roche’s Herceptin (trastuzumab), a humanized monoclonal antibody are currently under development.

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Trastuzumab interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Pivotal trials for candidate trastuzumab biosimilars being carried out typically include just one study of the response rate with some progression-free survival (PFS) data. 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 trastuzuzumab biosimilars

GW 2247G 8 table 1

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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 Nov 6]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

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