Over the last few years, the use of biological medicines has significantly increased due to the demographic changes and new treatment approaches. In Slovenia, the availability of biologicals is comparable to that of other European countries. However, statistics show that the prescribing of biosimilar medicines in Slovenia and in some other European countries is still relatively low (IQVIA, 2022).
Increased competition between biological medicines has the potential to deliver significant savings, which consequently provide more treatment options for patients and healthcare professionals and ultimately increase the availability of these medicines. It is foreseen that the market of biosimilars will increase in the following years and will be available for different therapeutic areas such as cancer, chronic inflammatory skin diseases, neuromuscular diseases, metabolic diseases, diabetes, neutropenia, growth disorders, osteoporosis, etc. So far, about three and more biosimilars of the same reference product are already available on the European market (EMA: Human, Biosimilars). Therefore, it is essential to strengthen the confidence in biosimilar medicinal products.
It should be noted that so far none of the biosimilars authorized in the EU have been withdrawn from the market or withdrawn for safety or efficacy reasons. In addition, data from a few clinical studies showed that the interchangeability of originator with biosimilar is safe and it is not expected to trigger or enhance immunogenicity (Kurki, P. et al. (2021); Pinheiro, L.C., (2021); Druedahl, L.C. (2022); Barbier, L. (2020).
It is believed that the active post-marketing surveillance of switch-related adverse events by registries as well as improved adverse event reporting and analysis could provide the necessary safety net and support the interchangeability Kurki P. et al. (2017).