The third AIFA Position Paper on biosimilar medicines is now available. The updated document revises the previous 2018 edition in light of recent regulatory developments related to procurement procedures and follows the Joint Statement issued in 2023 by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) on the interchangeability of biosimilar medicines.

The new text was approved by AIFA’s Scientific and Economic Committee (CSE), discussed within the AIFA-Regions Working Group, and ultimately finalised through the active involvement of stakeholders -including scientific societies, patient associations and pharmaceutical industry trade organisations -who had the opportunity to provide their input during a dedicated webinar held on 9 April.

Interchangeability and "informed switching"

In line with European guidance recognising that biosimilar medicines authorised in the EU are scientifically considered interchangeable with their respective reference products, AIFA considers the benefit–risk profile of biosimilars to be equivalent to that of originator medicines. Accordingly, biosimilars are deemed interchangeable both in treatment‑naïve patients (at treatment initiation) and in patients already undergoing therapy.

With the aim of promoting resource‑conscious use and encouraging the prescription of lower‑cost medicines within the National Health Service (NHS), the document introduces a strong recommendation in favour of so‑called “informed switching”.

Under this procedure, the pharmacist, subject to the consent of the prescribing physician, may substitute the prescribed medicinal product with another off‑patent biotechnological medicinal product or a biosimilar medicine, selected from among the products awarded under the regional framework agreement. This is carried out while ensuring full traceability of both the prescription and the dispensing process, as well as the provision of adequate information to the patient.

AIFA recommends that, for treatment‑naïve patients, therapeutic choices be made from among the medicinal products awarded through the regional procurement procedure. For patients already undergoing treatment, it is instead advisable, where appropriate, to assess the feasibility of a therapeutic switch to the tender‑awarded products.

In all cases, the treating physician’s freedom of prescription is safeguarded; should the physician deem it necessary to select alternative products within the framework agreement, the clinical rationale for such a decision must be duly documented.

Economic sustainability and access to therapies

Biotechnological therapies represent a fundamental resource for the treatment of serious and debilitating diseases; however, they are also associated with a significant economic impact. The adoption of biosimilar medicines, priced at least 20% below the originator product, fosters effective competition in the pharmaceutical market. The resulting savings are crucial for the sustainability of the NHS and enable reinvestment in access to the most innovative therapies for an increasing number of patients.

The update of the Position Paper constitutes a key instrument for promoting the containment of pharmaceutical expenditure related to biotechnological medicinal products, while fully preserving the prerogatives and ultimate responsibility of the individual Regions with regard to its practical implementation and the execution of framework agreements.

Published on: 29 April 2026