Latin American deal for infliximab biosimilar

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Latin American deal for infliximab biosimilar

Biosimilares/Novedades | Posted 29/05/2015 0 Post your comment

US-based Epirus Biopharmaceuticals (Epirus) announced on 14 May 2015 that it had made a deal with biosimilars specialist mAbxience, a subsidiary of Spanish healthcare firm the Chemo Group, for Latin America with respect to the infliximab biosimilar made by Epirus.

The deal covers development and future distribution of BOW015 (infliximab) for Latin American markets, including Argentina, Chile, Ecuador, Paraguay, Uruguay and Venezuela.

Leveraging the Chemo Group’s global infrastructure, mAbxience will be responsible for regulatory submissions, using BOW015’s existing data package, and eventual commercialization in these selected Latin American markets.

BOW015 is a biosimilar of Johnson & Johnson’s blockbuster arthritis treatment Remicade, which was approved by the European Medicines Agency in August 1999. Remicade had worldwide sales of US$6.9 billion in 2014, the patent in the US expired in 2011, in Japan and elsewhere globally the patent expired in 2014 and in the European Union (EU) patent protection on Remicade expired in February 2015.

South Korean biosimilars maker Celltrion and US-based Hospira gained approval for their infliximab biosimilar (Remsima/Inflectra) in the EU in September 2013 [1].

Epirus has also made a licensing agreement for BOW015 with Indian generics maker Ranbaxy Laboratories (Ranbaxy). Under the terms of that agreement, Epirus will develop and supply BOW015, and upon regulatory approval Ranbaxy will market the ‘similar biologic’ in India and other emerging markets, including South East Asia and North Africa [2].

Epirus received Indian approval for its Infliximab ‘similar biologic’ in September 2014 [3].

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References
1.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2.   GaBI Online - Generics and Biosimilars Initiative. Epirus and Ranbaxy sign agreement for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 29]. Available from: www.gabionline.net/Biosimilars/News/Epirus-and-Ranbaxy-sign-agreement-for-infliximab-similar-biologic
3.   GaBI Online - Generics and Biosimilars Initiative. Infliximab ‘similar biologic’ receives Indian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 29]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-similar-biologic-receives-Indian-approval

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Source: Epirus