Recently, the Italian Medicines Agency (AIFA) has published a new Concept Paper on Biosimilars.  The Concept Paper outlines the regulatory status of biosimilars in Italy as well as their importance for the Italian healthcare sector.

The new Concept Paper constitutes a revision of AIFA’s Position Paper on Biosimilars of 13 May 2013.  Overall, the Concept Paper does not differ significantly from the Position Paper of 2013.  In fact, both Papers indicate that it is for the physician to decide on a case-by-case basis whether to treat a patient with a biosimilar or with the innovative biologic.  They also exclude the automatic substitution between biosimilars and their originators.

However, AIFA has introduced a few relevant changes in the Concept Paper.  For example, the Concept Paper does not state anymore that biosimilars “should be preferred – where they  constitute an economic advantage – in the treatment of naïve patients.”  Instead, the Concept Paper now indicates that “biosimilars constitute a therapeutic option whose risk-benefit balance is identical to that of their originators.”  The Concept Paper states that this also applies to non-naïve patients, but specifies that in this case “the opportunity of the change is left to the clinical assessment of the physician.” This suggests that AIFA is open to more biosimilar switching in non-naïve patients.

AIFA’s position on biosimilars is also driven by budgetary concerns around the use of expensive biologic drugs in hospitals.  In this regard, the Concept Paper indicates that the use of biosimilars may contribute to the sustainability of the Italian healthcare expenditure.  In fact, in Italy, the price of biosimilars is at least 20% lower than that of their originators.

The Concept Paper is open for comments.  Interested stakeholders may submit their comments to by 15 September 2016.  Comments should be submitted by using a specific form available on AIFA’s website.