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Amneal and mAbxience make deal for bevacizumab biosimilar Posted 29/06/2018

US generics maker Amneal Pharmaceuticals (Amneal) and biosimilars specialist mAbxience, a subsidiary of Spanish healthcare firm Insud Pharma (formerly the Chemo Group), announced on 23 May 2018 that they have signed an exclusive licensing and supply agreement in the US for mAbxience’s candidate bevacizumab biosimilar.

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

According to the deal, which is based on milestone achievements, mAbxience will lead product, clinical development and manufacture of the bevacizumab biosimilar. Amneal will guide the product through regulatory approval and have exclusive commercialization rights in the US.

The originator product, Roche’s Avastin (bevacizumab), had 2016 sales of CHF 6.8 billion (Euros 5.95 billion) before the advent of biosimilars. The patents on Avastin will expire in the US in July 2019 and in Europe in January 2022 [1].  Despite these dates, Amgen received marketing approval for its bevacizumab biosimilar, Mvasi (ABP 215), from both the US Food and Drug Administration (FDA) [2] and the European Commission (EC) [3] in September 2017 and January 2018, respectively.

mAbxience says that it is progressing its international expansion and has recently established partnerships in Europe and Australia for its bevacizumab biosimilar. The company also made a deal with Brazil-based Libbs Farmacêutica (Libbs) for mAbxience to produce seven biosimilars back in 2013 [4].  In 2015, it made a deal with US-based Epirus Biopharmaceuticals (Epirus) for the infliximab biosimilar BOW015 for Latin American markets, including Argentina, Chile, Ecuador, Paraguay, Uruguay and Venezuela [5]. However, GaBI Online was informed in July 2018 by mAbxience that the deal with Epirus is now off.

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References
1.  Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2.  GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi
3.  GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-bevacizumab-biosimilar-Mvasi
4.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars agreements for Hospira and mabXience [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/Biosimilars-agreements-for-Hospira-and-mAbxience
5.  GaBI Online - Generics and Biosimilars Initiative. Latin American deal for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/Latin-American-deal-for-infliximab-biosimilar

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Source: mAbxience

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