A biosimilar medicine is one that shows a high level of similarity to an existing approved biological medicine, known as the "reference product." Interchangeability refers to the practice of substituting one medicine with another, as long as the therapeutic effect remains consistent. In this case, it means replacing a reference product with a biosimilar that will provide the same clinical outcomes.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement, supported by an analysis of over a million patient-treatment years with no safety concerns raised. The statement confirms that once a biosimilar is approved in the EU, it can be substituted for the reference product or replaced by another biosimilar of the same reference product. Although several EU member states already allow such interchangeability, the joint statement aims to harmonize and standardize this practice across the EU.
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