Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU

EU experts have issued a collective statement concerning the interchangeability of biosimilar medicines. Biosimilar Medicines Working Party (BMWP) and the Biosimilar Working Group of the Heads of Medicines Agencies (HMA) in the European Union (EU) enlighten the regulatory world on the scientific basis for classifying EU-approved biosimilars as interchangeable. ).

1. The HMA and the EMA affirm that upon approval in the European Union, a biosimilar is considered interchangeable. This indicates that the biosimilar can be utilized interchangeably with its reference product, or alternatively. However, it is essential to exercise caution and carefully evaluate the approved conditions of use, including consulting the most up-to-date product information, before undertaking any interchange.

2. The responsibility for determining the implementation of interchangeability, including switching and substitution, lies with individual member states. These decisions are not within the purview of the European Medicines Agency (EMA).

statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines - EMA review following PROM endorsement (europa.eu)