GABI Publishes Data on Italian Biosimilar Landscape

A paper published in the Generics and Biosimilars Initiative Journal reports on “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.”

The paper, which was based on studies funded by the Italian Ministry of Health, evaluated the pattern of use and the comparative effectiveness of biological drugs and biosimilars in Italy.

The paper reports increasing biosimilar uptake across Italy, but notes variability in different regions across the country.  The paper advances several potential reasons for this, including “different healthcare policy interventions promoting biosimilar use adopted at a loco-regional level,” “different tender procedures for the purchase of originators and biosimilars by public hospitals,” “the scepticism surrounding biosimilars,” and “the differences in patients’ access to biological drugs.”

The paper also reports that, while automatic substitution is not allowed by the Italian Medicines Agency (AIFA), switching between different active pharmaceutical ingredients within the same therapeutic class (i.e., from one originator to another) is frequent during the first year of treatment.

For more details, the paper can be found here.