The high growth rates in the global biologicals market and the huge gains to be made from making biosimilars of these blockbusters is fuelling growth, but many challenges remain. Despite this, the number of companies entering the biosimilars arena is expanding.

Just a few of the many players now busy with biosimilars can be seen in Figure 1.

The companies entering the biosimilars field differ not only in their geographical spread but also in their wider biologicals portfolio. This is not surprising when considering the possibility of huge rewards. According to research firm Datamonitor, US$60 billion in annual sales will lose patent protection by 2015 [2].

It should be noted that biosimilars approved in countries outside the EU may not have been authorized following as strict a regulatory process as is required for biosimilars in the EU. 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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References
1.   Sheppard A. Biological/biotechnological and biosimilars market: the global outlook with special focus on Europe. 12th EGA International Symposium on Biosimilar Medicines; 3-4 April 2014; London, UK.
2.   GaBI Online – Generics and Biosimilars Initiative. Generics manufacturers and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Generics-manufacturers-and-biosimilars