Global and national biosimilars players increasing

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The number of players in the biosimilars field is increasing with both originator and generics manufacturers devoting resources to biosimilars. This applies to global companies as well as to national players [1].

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.

Figure 1 V14K13

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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 

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comment icon Comments (3)
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Posted 02/06/2015 by Bioconsultant
Figure with national/international and emerging markets

which countries do you mean when you list national and international. Thanks

Posted 14/11/2014 by Justyna K, GaBI Online Editorial Office
Response to ‘Domestic’

Dear John, Thank you for your comment/. We updated the word ' domestic ' to national for clearer understanding. Kind regards, Justyna

Posted 08/10/2014 by John
Domestic

By domestic, which country is meant?

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