EMA confirms interchangeability of biosimilars in EU

Sep 19, 2022

The EMA’s Biosimilar Medicines Working Party and the Heads of Medicines Agencies Biosimilars Working Group issued a joint statement (which was endorsed by the CHMP and the Biologics Working Party), confirming that biosimilar medicines approved in the EU are interchangeable with the reference product or with an equivalent biosimilar.  Previously, interchangeability was permitted if the national regulatory agency allowed it, and EMA had not previously issued an official position on interchangeability.  EMA confirmed that substitution at the pharmacy level will remain a matter for national governments.  It is hoped that this harmonised approach will provide clarity for healthcare professionals prescribing biologics.

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