ROMA (ITALPRESS) – Ten years ago Law 232/2016 introduced a model that over time has established itself as a reference at European level, helping to combine access to biosimilar drugs, prescribed freedom of the doctor and sustainability of the National Health Service. Today, while Italy is confirmed among European countries with the highest use of these medicines, that model is called to confront new challenges: In recent years, race management models have increasingly focused on achieving maximum savings in the short term. This led to increased pressure on prices and a concentration of volumes on the first contractor. However, these dynamics raise some critical issues, particularly on market sustainability, supply continuity and the overall capacity of the supply chain to resist unforeseen.
It is from here that the comparison promoted by the Italian Biosimilars Group (IBG) of Egualia entitled “Biosimilari in Italy, 10 years from the Law 232/2016 between governance, sustainability and new challenges” organized in Rome with the participation of institutions, scientific communities, associations of patients and operators of the sector to take stock of the first ten years of application of the norm and discuss the future prospects of the governance of biosimilars in Italy.
To open the debate the presentation of the preliminary results of the economic study carried out in collaboration with Giorgio Lorenzo Colombo, President and Scientific Director of the Research Centre S.A.V.E. Economic Analysis and Evaluations, which deepens the relationship between sustainability of expenditure, competitive market dynamics and resilience of the supply chain of biological and biosimilar drugs. “The biosimilars have shown that they can expand access to care and generate significant savings for the National Health Service. The first evidence of our study – Colombo has explained – indicates that it is not enough to look at how many biosimilars are used: the true result is measured in the ability to treat more patients and to reduce the cost of therapies. The challenge is to preserve over time the conditions that have allowed us to achieve these results.”.
The results achieved so far are significant: Italy is today one of the leading European biosimilar markets and the sector has contributed over the years to generate important savings for the SSN, expanding access to care for a growing number of patients. To confirm it the data of the Annual Report on the market of biosimilars of the Egualia Study Office from which it emerges that in 2025 the 21 biosimilar molecules on the market have recorded an increase of consumption of +7% against a contraction of – 6.1% of the sales of all other biological drugs, they override the parterre of the corresponding originators and ensuring almost 55% of the reference market (51.2% in 2024).
However, the results obtained must not underestimate some of the issues that emerged in the application at regional level. In several territorial realities, in fact, the competition between the operators previewed from the framework agreement has gradually reduced in favor of the only first contractor. A trend that is likely to affect the sustainability of the market and the ability of the supply chain to respond effectively to the requirements of continuity of supply for the healthcare system with potential negative effects on patients. The concentration of supply on a single supplier reduces, in fact, the ability of the system to react promptly to any shortcomings or interruptions of supplies, with possible repercussions on therapeutic continuity.
“Patients call for uniform access to treatment and therapeutic continuity. Organizational and purchasing choices – said Silvia Tonolo, President of ANMAR (National Association of Rheumatic Diseases) – should not result in changes in treatment not motivated by clinical needs, with possible repercussions on the treatment path. It is therefore essential to preserve a system that guarantees availability of therapies, care continuity and protection of patients in a homogeneous manner throughout the Italian territory, overcoming the situation “to stain of leopards” typical of the Italian regions. The therapy cannot be considered an exclusively administrative choice: it must remain the result of a shared evaluation between doctor and patient, in compliance with the principles of appropriateness, personalization of care and therapeutic continuity. Ensuring equity of access means ensuring each person the opportunity to receive treatment more appropriate to their clinical condition, regardless of the Region of residence”.
The theme is further relevant in the light of the global market prospects. According to recent industry analysis, more than 75% of patent-expired biological drugs by 2032 may not have biosimilars in development, with a potential impact on expected savings for European health systems A scenario that makes even more central the ability to preserve conditions favourable to the development and permanence of operators in the market at the expense of patients. Not by chance the recent III Position Paper AIFA on biosimilar drugs recalls some of the key principles of Law 232/2016, reaffirming the value of a model based on the clinical evaluation of the doctor, the correct information of the patient and the presence of a plurality of operators able to guarantee continuity of supply and sustainability of the system.
“The call to Law 232/2016 contained in the new Position Paper AIFA represents a very important signal for us – said Francesca Romana Ramundo, Vice-President Egualia and Coordinator of the Italian Biosimilars Group of Egualia – especially in light of the applications not always homogeneous that we have observed in these years at regional level. The hope is that, we can start a dialogue between Parliament, Industry, Aifa and the Conference of Regions in order to identify a common and shared platform for dealing with current issues, also through the current review of the Single Pharmaceutical Text” so that the standard can find a coordinated and uniform application across the national territory, contributing to overcome the criticalities reported by patient associations and scientific societies.”.
– Photo Ipa Agency –
(ITALPRESS).
