The reports published by the Italian Medicines Agency (AIFA) analyse trends in consumption and expenditure (January 2019 - September 2020) and regional variability (January - September 2020) in the use of biosimilars in Italy.

The incidence of use of these medicines varies by type of molecule and by Region. At national level, an increasing trend in consumption is registered, especially regarding molecules used in more recently marketed biosimilars.

Price trends are influenced by medicines’ availability. Where biosimilars are most present, a decrease in price trends is more likely. Moreover, the profound price heterogeneity between Regions is linked not only to the penetration of biosimilars, but also to the different degree of effectiveness of tendering procedures.

The analyses include a total of 12 therapeutic categories (ATC level IV), with specific details on individual patent-expired molecules and the various routes of administration.

The trend in consumption and prices of biosimilars, both at national and Regional level, is compared with that of the reference medicine and other products belonging to the same therapeutic category.

The analysis highlights regional deviations from national average values in terms of expenditure and consumption, and postulates the potential savings that each Region could achieve by aligning the average price paid with the national average value.

The aim of the reports is to provide useful information to actors involved in the monitoring and governance of pharmaceutical expenditure, in order to promote the use of patent-expired medicines, assess the effectiveness of regional tenders, identify areas of intervention and monitor the impact of the policies introduced.