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In brief

On 19 May 2021, the AIFA published the updated reports on the monitoring of biosimilar drugs in Italy which analyze the consumption and expenditure trends in the period from January 2019 to December 2020 and the the use of said drugs at the regional level in the period from January to December 2020. The purpose of the reports is to provide those individuals responsible for the monitoring and governance of pharmaceutical expenditure with useful information to promote the use of patent-expired medicines, assess the effectiveness of regional tenders, identify areas of intervention and, lastly, monitor the effects of the adopted policies.

What’s new

The analysis carried out by the AIFA is reflected in three separate reports which show that (i) in the reference period there has been an increase in the consumption of biosimilar drugs; (ii) the average sales prices applied in the various Regions significantly differ, also in light of the different effectiveness of public tenders and penetration of biosimilars, and (iii) the price trend – which covers originators, the relevant biosimilars and other patented-protected medicinal products belonging to the same category – is conditioned by the availability of the different drugs and that the presence of biosimilars leads to its reduction.


Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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