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Mabion signs agreement with Mylan for rituximab biosimilar Posted 20/01/2017

Global specialty pharmaceuticals firm Mylan has reached an agreement with Mabion, a leading biotechnology company in Poland, for the exclusive right to commercialize their rituximab biosimilar candidate in the European Union (EU).

Rituximab is a monoclonal antibody against the protein CD20 found on the surface of B cells. By destroying overactive or dysfunctional T cells it is used to treat several diseases of the immune system, including cancers of the blood (lymphoma and leukaemia), transplant rejection and autoimmune disorders. Rituximab is thus listed on the World Health Organization (WHO) List of Essential Medicines [1].

The originator drug is currently marketed in the EU as MabThera by Roche. MabThera had sales of over Euros 6 billion in 2015 [2], however, its patent expired in Europe in February 2013 [3]. Mabion’s biosimilar version, Mabion CD20, was approved for clinical trial in 2015 [4].

Mabion, a biotechnology company focused on humanized monoclonal antibodies, signed the development and commercialization agreement with Mylan Ireland (a subsidiary of Mylan NV) on 8 November 2016, giving Mylan the right to commercialize the rituximab biosimilar in the EU and non-EU Balkan states.

The deal involved an upfront payment of US$10 million as well as milestone payments and royalties of up to US$35 million, subject to filing and approval of marketing authorizations, commercial launch in key countries and royalties based on annual sales.

Mylan reported that it will support Mabion in its attempts to secure approval for the drug from the European Medicines Agency (EMA). Mabion also commented on their excitement on finalizing the collaboration, which will give them access to Mylan’s expertise in generics and biosimilars. The company hopes to commercialize Mabion CD20 after its EMA approval, stating that the partnership could benefit patients across the EU.

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References
1.   World Health Organization. 19th WHO Model List of Essential Medicines (April 2015) [homepage on the Internet]. [cited 2017 Jan 20]. Available from: www.who.int/medicines/publications/essentialmedicines/EML2015_8-May-15.pdf
2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab
3.   GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
4.   GaBI Online - Generics and Biosimilars Initiative. Mabion starts phase III trial for rituximab biosimilar. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from: www.gabionline.net/Biosimilars/News/Mabion-starts-phase-III-trial-for-rituximab-biosimilar

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Source: Mabion

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