Biosimilars: risks regarding tenders and access to treatment – reviving the Italian model

Ten years have passed since the enactment of Law 232/2016, which introduced a model that has, over time, established itself as a benchmark at European level, helping to balance access to biosimilar medicines, doctors’ freedom to prescribe, and the sustainability of the National Health Service. Today, this model is under pressure: in recent years, tender management models have increasingly focused on achieving maximum short-term savings through price reductions and the concentration of volumes on the successful bidder. These trends raise a number of concerns, particularly regarding market sustainability, continuity of supply and the supply chain’s overall capacity to withstand unforeseen events. These issues were discussed in Rome at a round-table organised by the Italian Biosimilars Group (IBG) of Egualia.

“Biosimilars have been shown to broaden access to treatment and generate significant savings for the National Health Service,” explains Giorgio Lorenzo Colombo, Professor of Economics at the University of Pavia and President and Scientific Director of the S.A.V.E. Research Centre. Studies, Analysis and Economic Evaluations – . Initial findings from our study suggest that it is not enough to look at how many biosimilars are being used: the true outcome is measured by the ability to treat more patients and reduce the cost of treatments. The challenge is to maintain, over time, the conditions that have enabled these results to be achieved.”

In Italia in 2025, the 21 biosimilar medicines on the market – which offer the same quality, efficacy and safety as the reference medicines no longer covered by patent – recorded a 7% increase in consumption, whilst sales of all other biological medicines fell by 6.1%, overtaking the corresponding originator medicines and securing almost 55% of the relevant market (51.2% in 2024).

Credit is also due to the Italian Medicines Agency, which, in its recent Third Position Paper on biosimilar medicines, highlighted some of the key principles of Law 232/2016, reaffirming the value of a model based on the clinician’s assessment, on providing patients with accurate information, and on the presence of a diverse range of healthcare providers capable of ensuring continuity of supply and the sustainability of the system. “Biosimilars are a strategic tool for ensuring access to care and the sustainability of the National Health Service,” emphasises AIFA’s Technical and Scientific Director, Pierluigi Russo -. AIFA’s third position paper aims to further strengthen their use by introducing the recommendation for the so-called ‘informed switch’ and reaffirming the central role of the framework agreement as a model for the procurement and supply of these medicines, capable of stimulating market competition and ensuring a wide range of treatment options for patients”.

According to recent industry analyses, over 75% of biologics whose patents are due to expire by 2032 may not have biosimilars in development, with a potential impact on the expected savings for European healthcare systems. This scenario makes it even more crucial to maintain conditions that are conducive to the development and continued presence of market players.