Biosimilars approved in the EU are interchangeable. The EU experts on biosimilar medicines (Biosimilar Medicines Working Party or BMWP) and the Heads of Medicines’ Agencies (HMA) Biosimilar Working Group have drafted a joint statement explaining the rationale for considering biosimilars approved in the EU as interchangeable from a scientific perspective. This statement has been endorsed by the Committee for Medicinal Products for Human Use (CHMP) and the Biologics Working Party (BWP).
Approved biosimilars have demonstrated comparable efficacy, safety, and immunogenicity compared with their reference products. Thus, EU experts considered that when approval for a biosimilar is granted in the EU, additional systematic switch studies are not required to support the interchangeability at the prescriber level.
The full statement can be accessed here.