Xbrane has developed two systems for efficient protein production (the Lemo System and the Rhamex System). These systems also work for those proteins that have traditionally been difficult to produce, e.g. membrane and host-toxic proteins.

Xbrane will help optimize the Indian pharmaceutical company’s production system for the specific biosimilar in order to obtain the highest possible yield at the lowest cost.

According to Xbrane, the biosimilar market is the fastest growing area within the biologicals market at the moment. Xbrane estimates that more than 30 brand-name biologicals, generating sales of US$51 billion, are set to lose patent exclusivity between 2011 and 2015. Mr Siavash Bashiri, CEO of Xbrane, quotes forecasts that predict the global biosimilar market will have grown from US$243 million in 2010 to US$3.7 billion in 2015.

Xbrane’s aim is to penetrate the biosimilar market by introducing their unique protein production platform and enabling clients to keep production costs down.

Editor’s comment
It should be noted that ‘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. The EMA (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.

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