Press release No 5/2024 - “The fight against shortages also requires acknowledging the need to make many essential medicines economically sustainable. We have been working on this issue”, so AIFA’s President, Robert Nisticò at the end of the first meeting with Stefano Collatina, President of EGUALIA (equivalent medicines, biosimilars, value added medicines industries), held at the Agency’s headquarters. 

The need was pointed out to focus attention and efforts on tackling the phenomenon of shortages, so that essential and critical drugs for all chronic therapies, where equivalent and biosimilar drugs are an essential resource, continue to be made available to patients without interruption. A technical working group will then be launched to identify specific tools and measures to address the issue of industrial economic sustainability of equivalent and biosimilar drugs. “It will be necessary to complement the current procedures with tools aimed at determining the factors making widely used drugs not available continuously, or worse, causing their shortages, and act accordingly – so AIFA’s Scientific-Technical Director, Pierluigi Russo – in order that, within the overall expenditure constraints, these drugs remain economically and industrially sustainable for companies”.

EGUALIA highlighted data on the significant gap in the use of equivalent medicines between Italian regions, as well as the high expenditure of over EUR 1 billion incurred by Italian patients each year when they do not choose a drug equivalent to the reference price, which is significantly concentrated in Southern Italy. 
 
With a view to simplification, the commitment was also shared to continue the work of simplifying authorisation and pricing and reimbursement procedures through a working group. This will streamline workflows for the newly formed Scientific and Economic Committee (CSE) of the Agency, precisely on the procedures concerning equivalent and biosimilar medicines.