Biosimilar Development in Europe: Ten Years On

August 12, 2014
Guest Blogger

Pharmaceutical Executive

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006.

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, in the light of its experience.  

In this special Pharmaceutical Technology Europe feature, Fiona Greer looks at what the future holds for biosimilars in Europe.

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