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Deal struck over development of Herceptin biosimilar Posted 03/08/2012

Netherlands-based biopharmaceutical company Synthon announced on 18 July 2012 that it has entered into a global licensing agreement with Amgen and Watson Pharmaceuticals for the clinical development and testing of biosimilar trastuzumab as an alternative to Roche’s blockbuster anticancer agent Herceptin. The deal follows the results of a phase I trial reported on 22 March 2012 showing bioequivalence between Synthon’s trastuzumab and Herceptin [1].

The deal enables Watson Pharmaceuticals to oversee all phase III clinical testing in breast cancer patients as well as the global manufacturing and commercialisation. Synthon will provide transitional support in return for an undisclosed initial payment, and potentially gains a milestone fee and a portion of net sales.

Meanwhile, Synthon will continue to develop independently a HER2-targeted antibody-drug conjugate candidate using proprietary technology.

Trastuzumab and Synthon’s biosimilar are humanised monoclonal antibodies that target the HER2 receptor, which was originally found to be over expressed on breast cancer cells. Trastuzumab is currently used to treat both breast cancer and gastric cancer.

The patents on Herceptin are set to expire in Europe in July 2014 and in the US in June 2019 [2]. Generics giants Hospira and Stada are also reportedly working on their own biosimilar versions of trastuzumab, so it looks like there will be no shortage of competition once the patents on Herceptin expire.

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1.  GaBI Online - Generics and Biosimilars Initiative. Also noted on biosimilars: 30 March 2012: Bioequivalence of biosimilar trastuzumab to Herceptin proven in phase I trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Aug 3]. Available from: www.gabionline.net/Biosimilars/General/Also-noted-on-biosimilars-30-March-2012

2.  GaBI Online - Generics and Biosimilars Initiative. US$54 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Aug 3]. Available from: www.gabionline.net/Biosimilars/Research/US-54-billion-worth-of-biosimilar-patents-expiring-before-2020

Source: Amgen, Synthon

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