Biosimilars in Italy: a new regime

Since the approval of the first biosimilar in Europe, in 2006, biosimilars have gained momentum. Currently, 25 biosimilars have been centrally approved in the EU, and over a dozen biosimilar applications are under evaluation by the European Medicines Agency. Their number is likely to increase substantially in the next few years due to the upcoming patent expiry of several blockbuster biologics.

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