Biosimilar Medicines

26 April 2023 – the EMA published an updated statement and Q&A guidance on the scientific rationale supporting interchangeability of biosimilars medicines in the EU.

Statement on the Scientific Rationale Supporting Interchangeability of Biosimilar Medicines in the EU

This joint EMA-HMA statement explains the rationale for considering biosimilars approved in the EU as interchangeable from a scientific perspective. Interchangeability refers to the possibility of exchanging one medicine for another medicine that is expected to have the same clinical effect. How this is implemented is the responsibility of the individual member states.

Q&A Statement

Following the publication of the joint EMA-HMA statement on interchangeability of biosimilar medicinal products approved in the EU, both EMA and National Competent Authorities (NCAs) have received questions for clarification from healthcare professionals and other members of the public. This questions and answers (Q&A) document addresses follow-up questions received after publication of the statement.

Updated Statement Q&A Statement 
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