OBJECTIVES: European Union (EU) is the most advanced biosimilar market, with 28 products already authorised. Since establishment of the regulatory pathway for biosimilars in 2005, much effort has been made at EU level to stimulate biosimilar adoption. The objective of this research was to identify the most important initiatives undertaken in the biosimilars field.

METHODS: Websites of the European Commission (EC), European Parliament (EP) and European Medicines Agency (EMA) were searched to identify Pan-European projects enhancing launch and adoption of biosimilars.

RESULTS: CONCLUSIONS: Given their potential to generate savings on pharmaceutical expenditures, new biosimilars are eagerly awaited by health authorities. While drug policies remain under Member States’ competences, EU initiatives contribute to boosting national policies dedicated to biologics and biosimilars.