With its Third Position Paper on biosimilar medicinal products, the Italian Medicines Agency (AIFA) updates its policy framework in light of developments at the European scientific and regulatory level, confirming previously established principles while clarifying certain aspects of practical application.

The document reiterates that biosimilars are not generic medicines, but biological medicinal products similar to an already authorised reference product, whose assessment is based on a rigorous comparability exercise aimed at excluding clinically meaningful differences in terms of quality, safety and efficacy. In continuity with the previous Position Paper, alignment with the European framework is further strengthened, with specific reference to centralised procedures and EMA guidelines.

The strategic role of biosimilars within the National Health Service is reaffirmed, as lower-cost therapeutic options capable of enhancing system sustainability, expanding access to care and supporting the introduction of innovative therapies.

The new Position Paper incorporates the position developed at European level, according to which authorised biosimilars may be considered interchangeable with their respective reference products, as well as with one another where they refer to the same originator, in view of the robustness of the regulatory assessment ensuring a comparable benefit–risk profile. While consistent with the previous document, this statement is now expressed in more precise terms.

In this context, particular relevance is given to AIFA’s recommendation to recognise, at national level, the possibility of an “informed switch”, whereby the pharmacist, having obtained the prescribing physician’s consent, substitutes the prescribed medicinal product with another off-patent biotechnological medicinal product or biosimilar among those awarded under the framework agreement, ensuring full traceability of prescription and dispensing, as well as appropriate patient information. AIFA further recommends, in the interest of sustainability and loyal cooperation, that for naïve patients prescriptions be oriented towards products awarded through regional tenders, and that, for patients already under treatment, a switch to awarded products be considered where appropriate. Any alternative choices must be supported by documented clinical justification. Regions are also required to promptly inform prescribing physicians and pharmacists of the awarded medicinal products.

The Position Paper also emphasises the importance of traceability and pharmacovigilance, through proper identification of medicinal products and risk management plans, with biosimilars being subject to additional monitoring.

Finally, patient associations, scientific societies and industry associations have highlighted the need for coordinated implementation of the Position Paper’s recommendations across Regions and have pointed out certain critical issues relating to public procurement procedures and framework agreements, with potential implications for therapeutic continuity and pharmacovigilance.