Abstract

Objectives

There is a paucity of evidence around the true economic value of biosimilars, especially in the long term. The aim of this study was to estimate the biosimilars uptake, cost trends of off-patent biologics and savings generated through the use of biosimilars in the Italian National Health Service in the 2013 to 2022 period.

Methods

We identified all biologics (ie, reference products) and related biosimilars that were approved in Europe and marketed in Italy until December 2022. The savings were estimated by multiplying sales volume for biosimilars by the difference between the reference product and biosimilars cost in each year.

Results

A total of 12 off-patent biologic medicines were included in the analysis, and in 2022, the mean uptake was 80%. It showed a descending trend of reference product and biosimilar cost, although, by maintaining a relevant difference. Italian National Health Service saved a total of 3.09 billion euros through the use of biosimilars, increasing over the study time period from 37.7 million euros to 762.6 million euros, representing 5% of overall pharmaceutical spending of public health facilities in 2022. The loss of savings due to the use of on-patent active ingredients, belonging to the same anatomical therapeutic chemical, was 1 billion euros.

Conclusions

The study confirmed a high biosimilar uptake in Italy and a decreasing trend in the mean cost per defined daily dose in the 2013 to 2022 period. Biosimilars led to important savings; however, major savings are obtainable by increasing the biosimilar uptake and preferring off-patent biologicals to on-patent medicines belonging to the same IV-level anatomical therapeutic chemical, when appropriate.