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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 is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.


Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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