Biosimilars in Italy: What do real-world data reveal?

This paper aims to provide an overview of the available real-world data about the pattern of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy. Different observational studies resulting from an Italian Ministry of Health funded project were described. These studies evaluated the pattern of use and the comparative effectiveness of biological drugs and biosimilars. In addition, further studies using Italian administrative databases to explore the switching patterns between biosimilars and originators and the clinical consequences of switching are described. The included studies highlighted a remarkable heterogeneity in biosimilar uptake across Italy, and an overall increasing trend in biosimilar use. During the first year of treatment, switching between drugs of the same class was common, occurring mostly between originators. When investigated, erythropoiesis-stimulating agent biosimilars and originators, a comparable effectiveness in terms of the haemoglobin levels gained after treatment beginning was demonstrated. Given the expected rise in the number of biosimilars, a combination of multiple healthcare databases from several countries may represent an opportunity for post-marketing monitoring of biological drugs.