What do I have to consider as a patient using biosimilar medicine?


Biologicals have the inherent potential to provoke (unwanted) immune reactions. Therefore, immunogenicity assessment through clinical studies plays a major role in the development of biological medicines.


Interchangeability of medicinal products refers to the situation where one product is “switched” for another equivalent product in a clinical setting, without a risk of an adverse health outcome. Regulatory agencies such as the European Medicines Agency (EMEA) do not assess the interchangeability or substitutability of a biosimilar.

Currently, no clinical studies have been designed or undertaken to assess the clinical outcome of repeated switches (changes) of a biological medicine, whether using two original biological medicines or an original and a biosimilar.


The EMEA has specifically stated that “since biosimilars and biological reference products are not identical, the decision to treat a patient with a reference product or biosimilar medicine should be taken following the opinion of a qualified health professional”*. In addition, there is currently no convincing scientific data to prove that repeated product switching of biological medicines (whether biosimilar versions or not) does not lead to negative clinical consequences.

For further information please see our publication about Biosimilar Medicines

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