Kyowa to market Sandoz’s rituximab biosimilar in Japan

Biosimilares/Novedades | Posted 12/02/2016 post-comment0 Post your comment

Biotech firm Kyowa Hakko Kirin (Kyowa) announced on 25 January 2016 that it had made a deal with Sandoz, the generics division of Novartis, for exclusive marketing rights to Sandoz’s biosimilar rituximab in Japan.

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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.

Sandoz is currently developing its rituximab biosimilar (GP2013). The company is carrying out a phase I trial in Japanese non-Hodgkin’s lymphoma patients, a phase I/II trial in rheumatoid arthritis patients and a phase III trial in lymphoma patients. These trials were/are expected to be completed in March 2015, November 2015 and December 2017, respectively [1].

Under the terms of this agreement, Sandoz will file for marketing authorization of the rituximab biosimilar and will manufacture the biosimilar, if approved. Kyowa will be responsible for all sales, marketing and promotion activities in Japan.

The cost for Kyowa will be to pay Sandoz an up-front fee and to pay subsequent payments for regulatory filing, regulatory approval, success-based milestones, royalties as well as a defined supply price for every order.

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1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 12]. Available from:  

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Source: Kyowa Hakko Kirin, Sandoz

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