Swedish biotech company Xbrane Bioscience (Xbrane) has signed an agreement with a global Indian pharmaceutical company to assist them in developing an optimized production system for a specific biosimilar that will be marketed worldwide. The aim is to help the client reduce production costs in order to gain a competitive advantage in the biosimilar market.
Xbrane signs biosimilar optimization deal with Indian pharma firm
Home/Pharma News | Posted 14/11/2014 0 Post your comment
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.
Related articles
Merck KGaA plans further investment in biosimilars
Biosimilars deals coming thick and fast
More biosimilars collaborations on the cards
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2014 Pro PharmaCommunications International. All Rights Reserved.
Source: Xbrane
Guidelines
FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling
WHO’s revised guideline to safe and effective biosimilar products
Policies & Legislation
Public consultation for the modification of the biosimilars regulation
Comments (0)
Post your comment