Italy has replaced its 2018 biosimilar position paper with a third AIFA position paper that aligns national guidance with the 2023 EMA-HMA position on biosimilar interchangeability and with Italy’s regional procurement model. The update clarifies how biosimilars should be used in both new and established patients, while preserving the prescriber’s role in clinically justified exceptions.
The Italian Medicines Agency (Agenzia italiana del farmaco, AIFA) published AIFA pubblica il Terzo Position Paper sui farmaci biosimilari: focus su intercambiabilità, “switch informato” e sostenibilità del SSN on 29 April 2026. The text was approved by the Scientific and Economic Commission (Commissione scientifica ed economica, CSE), shared through the AIFA–Regions table and finalised after input from scientific societies, patient associations and pharmaceutical industry bodies.
AIFA states that biosimilars approved in the EU have the same benefit-risk balance as their reference products and are considered interchangeable with originators. This applies both to treatment-naïve patients and to patients already receiving therapy. The paper also states that interchangeability may cover switching between the reference product and a biosimilar, and between biosimilars of the same reference product.
The paper introduces a strong recommendation for ‘informed switching’. Under this approach, a pharmacist may replace the prescribed medicine with a lower-cost off-patent biotechnology medicine or biosimilar awarded under the regional framework agreement. The pharmacist must first obtain the prescriber’s agreement and must ensure traceability of prescribing and dispensing, as well as adequate patient information.
For treatment-naïve patients, AIFA recommends choosing therapy from among the products that have won the regional tender. For patients already receiving treatment, it says a switch to awarded products should be considered where appropriate. The doctor retains prescribing freedom, but must document clinical reasons for choosing a different product within the framework agreement.
The paper strengthens the link between biosimilar policy, regional tendering and medicines-spending control. It gives regional procurement outcomes a more direct role in dispensing practice, while leaving implementation and framework-agreement execution with the regions.
Source: Italian Medicines Agency, AIFA
Link: AIFA pubblica il Terzo Position Paper sui farmaci biosimilari: focus su intercambiabilità, “switch informato” e sostenibilità del SSN (AIFA publishes third position paper on biosimilar medicines: focus on interchangeability, informed switching and sustainability of the National Health Service)
Related European link: European Medicines Agency and Heads of Medicines Agencies, Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU, first published 19 September 2022 and last updated 26 April 2023
Date: 29 April 2026
