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Interchangeability of biosimilar medicines confirmed by EMA and HMA

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement on the interchangeability of biosimilar medicines approved in the EU, confirming that these medicines are – from a scientific standpoint – interchangeable with their reference medicine or with an equivalent biosimilar.

The joint statement envisages to harmonise the EU approach to the use of biosimilars whilst fostering patient access to medicines necessary to treat diseases such as cancer, and confirms a practice that some Member States already adopt.  Pursuant to the joint statement issued on 19.09.2022, “HMA and EMA consider that once a biosimilar is approved in the EU it is interchangeable, which means the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product". The EMA-HMA statement is based on the experience gained with the assessment, authorisation, and monitoring of biosimilars, medicines that “have demonstrated comparable efficacy, safety and immunogenicity compared with their reference products”.

Interchangeability in the context of the EMA-HMA joint statement does not include substitution at the pharmacy level, a decision which remains the responsibility of the individual Member States.


europe, pharmaceuticals, regulation-pharma

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