According to the Italian Medicines Agency (AIFA), biosimilars helped Italy save more than €3.1 billion in pharmaceutical spending by public health facilities between 2013 and 2022, with 8 of every 10 biologic drug prescriptions in the country being biosimilars.

An analysis published in Value in Health Regional Issues found that biosimilars reduced drug spending by approximately 5% for the Italian National Health System, driven by rising use and lower prices of both originator biologics and their biosimilar equivalents.

The researchers identified all the biologics (reference products) and related biosimilars approved in Europe and marketed in Italy until December 2022. Savings were estimated by multiplying the biosimilar sales volume by the annual cost difference between the reference products and the biosimilars.

Expenditure and prescription volumes were extracted from the Medicines Utilization Monitoring Centre (Osservatorio Nazionale sull’impiego dei Medicinali, OsMed) administrative database.

Twelve off-patent biologic medicines were included: adalimumab, etanercept, infliximab, bevacizumab, epoetin, filgrastim, pegfilgrastim, follitropin, insulin glargine, rituximab, somatropin, and trastuzumab.

Patent protection for epoetin and filgrastim expired before 2013, and the biosimilars for the remaining products entered the market later.

Three active ingredients, ie, low-molecular-weight heparin, fast-acting insulin, and teriparatide, were excluded because public health facility spending accounted for less than 60%, and public tenders were not applied.

By 2022, the mean biosimilar uptake of all active ingredients reached 80%. Uptake exceeded 95% for bevacizumab, infliximab, rituximab, trastuzumab, and filgrastim. The uptake was 80%-90% for etanercept (80%), adalimumab (85%), pegfilgrastim (86%), and epoetin (90%).

Biosimilar and reference product use was lower for somatropin (58%) and follitropin (42%) and under 40% for insulin glargine.

For nine of the 12 active ingredients, the mean price difference between the reference products and biosimilars exceeded 100%, ranging from 13% to 359%.

“This study confirmed a high biosimilar uptake in Italy and a decreasing trend in the mean cost per cost per defined daily dose in the 2013 to 2022 period, both for biosimilars and reference products. However, the difference between the biosimilar and reference product cost was maintained high,” the authors wrote.

Over the study period, the Italian National Health Service saved a total of €3.09 billion, rising from €37.7 million in 2013 to €762.6 million in 2022, representing 5% of overall pharmaceutical spending by public health facilities in 2022.

Another study in France found that biosimilars generated €2.4 billion savings between 2012 and 2022.

AIFA experts noted that in the market for small-molecule generics, originator brands often retain a large market share after patent expiry, and prices tend to stabilise after an initial drop. Instead, in the biologicals market in Italy, “it seems that the effects of competition are disclosed in the subsequent years as well, leading to a descending trend in costs of both biosimilars and reference products.”

The authors anticipate further savings as new biosimilars enter the market, stating that “biosimilars also allow freeing up economic resources that can be used to treat a wider range of patients and addressing other aspects of patients care.”

​This story was translated from Univadis Italy.​