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