Epirus and Livzon collaborate on copy biologicals for China

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Epirus and Livzon collaborate on copy biologicals for China

Biosimilares/Novedades | Posted 10/10/2014 0 Post your comment

US-based Epirus Biopharmaceuticals (Epirus) announced on 25 September 2014 that it had signed a collaboration agreement with Chinese biotechnology company Livzon Mabpharm (Livzon).

The agreement will see Epirus and Livzon work together to develop, manufacture and commercialize up to five copy biologicals for the Chinese market. The first product the companies will work together on is BOW015 (infliximab). Epirus received approval for its infliximab similar biologic in India under the brand name Infimab in September 2014 [1].

Livzon will conduct any additional development work necessary for the approval of BOW015 in China and Taiwan and will also serve as the preferred supplier of BOW015 in these territories.

Dr Daotian Fu, CEO of Livzon, commenting on the agreement said that ‘Epirus’ robust pipeline, business strategy and experienced management coupled with the market potential of biosimilars, made this an exciting collaboration for Livzon. We look forward to building a substantial biosimilars business for the China market.’

China, one of the largest pharmaceutical markets in the world, has yet to issue biosimilars guidelines, although domestic copy biologicals have been on the market in China for 20 years. Copy biologicals in China therefore have to go through a new drug or generic drug approval process [2].

Editor’s comment
It should be noted that ‘copy biologicals’ approved in China and ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related articles
Strategy for biosimilars in China

Epirus and Ranbaxy sign agreement for infliximab biosimilar

References
1. GaBI Online - Generics and Biosimilars Initiative. Infliximab ‘similar biologic’ receives Indian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 10]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-similar-biologic-receives-Indian-approval
2. GaBI Online - Generics and Biosimilars Initiative. China to release biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 10]. Available from: www.gabionline.net/Guidelines/China-to-release-biosimilars-guidelines

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Source: Epirus