Italy's drug policy wrestles with rising costs and biosimilar sustainability

A decade after Italy introduced Law 232/2016 to promote biosimilar medicines, the model is praised for expanding patient access and generating significant savings for the National Health Service. A recent Ibg Egualia conference highlighted that biosimilars now account for about 55% of the market, with a 7% growth in consumption projected for 2025. However, participants warned that procurement practices increasingly favour a single awardee, pressuring prices in the short term and risking supply continuity and market resilience.

At the same time, members of the Five Star Movement have criticised the government's handling of pharmaceutical spending. Marianna Ricciardi noted that "the pharmaceutical expenditure rose by 5.4% last year" and warned that a proposed change to reimbursement rules would shift the cost of previously free medicines onto citizens. She added that "the government is increasing pharmaceutical spending while simultaneously dumping the cost onto the public, especially the most vulnerable."

These developments illustrate growing debate in Italy over drug pricing, reimbursement reforms, and the long‑term sustainability of its biosimilar framework.