CRED ERP 25

Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicines.

Biosimilar competition can offer advantages to EU healthcare systems, as it is expected to improve patients’ access to safe and effective biological medicines with proven quality.

EMA does not regulate interchangeability, switching and substitution of a reference medicine by its biosimilar. These fall within the remit of EU Member States.

4