Biosimilar medicinal products | Italian Medicines Agency Aifa toggle bar Search Search keywords The Agency The Agency Mission and values Organisation Scientific and Economic Committee for Medicines Support and Coordination Secretariats and Advisory Committees International Collaborations EU Projects Legislation Forms Competition notices Resolutions Tenders and contracts Quality assurance Guarantee Committee Atti di notifica Associazioni dei pazienti AIFA Incontra Contacts Certified email COVID-19 COVID-19 Communications about COVID-19 COVID-19 Vaccines Medicines usable for treatment of COVID-19 disease Use of monoclonal antibodies for COVID-19 Use of antivirals for COVID-19 Monitoring of medicinal products used during the COVID-19 epidemic Clinical Trials - COVID-19 Compassionate Use Programs - COVID-19 Access to medicinal products Access to medicinal products Early access and off-label use Authorisation of medicinal products Medicine shortages Antibiotic medicinal products Biological medicinal products Vaccines Blood derivatives Generic medicinal products Biosimilar medicinal products Orphan medicinal products Advanced therapies Homeopathic medicinal products Allergens Medicinali di origine vegetale Ancillary medicinal substances incorporated in medical devices Safety of medicinal products Safety of medicinal products Pharmacovigilance National Pharmacovigilance Network Adverse Reactions to medicinal products Persons in charge of Pharmacovigilance European Eudravigilance System Accesso alle segnalazioni - ADRreports Regional pharmacovigilance funds Segnali di sicurezza Risk management measures Medicinal products subject to additional monitoring Quality and Inspections Quality and Inspections Quality defects Inspections and authorisations Qualified person Fight of pharmaceutical crime Research and Clinical trials Research and Clinical trials Clinical trials concerning medicinal products EU Regulation on Clinical trials National Observatory on Clinical Trials Registro Studi Osservazionali Comitati Etici Nazionali (CEN) Ethics Committees Coordination Centre Independent clinical research Mappa dei centri di Sperimentazione Clinica Pricing and reimbursement Pricing and reimbursement Negotiation and reimbursement Economic evaluations Monitoring Registers AIFA Notes Lists of Class A and Class H medicinal products Innovative medicinal products Transparency Lists Consumption and pharmaceutical expenditure Consumption and pharmaceutical expenditure The Medicines Utilization Monitoring Centre (OsMed) Governance of pharmaceutical expenditure Monitoring pharmaceutical expenditure Innovation and planning Innovation and planning Innovation and scientific advice Horizon scanning Information and communication Information and communication FarmaciLine Medical and scientific information FAQ Publications Communication campaigns Eventi AIFA Scientific Seminars Press releases Dossier AIFA Mobile APP AIFA APP Firstline AIFA - Antibiotici ABC della Ricerca Clinica Presentations and speeches Public consultations and documents Documents shared with scientific communities Calendario eventi Archivio AIFA data AIFA data OsMed Data Open Data Companies Section Companies Section Requests for authorisation of conferences and meetings Payment of fees and annual duties MA Electronic invoicing Application for reimbursement and pricing Access information Notifica concessionari di vendita Comunicazione prima commercializzazione Open governance Open governance Disposizioni Generali Organizzazione Consulenti e collaboratori Personale Bandi di Concorso Performance Enti controllati Attività e procedimenti Provvedimenti Bandi di gara e contratti Sovvenzioni, contributi, sussidi, vantaggi economici Bilanci Beni immobili e gestione patrimonio Controlli e rilievi sull'Amministrazione Servizi Erogati Pagamenti dell'Amministrazione Opere pubbliche Pianificazione e governo del territorio Informazioni ambientali Interventi straordinari di emergenza Altri Contenuti Biosimilar medicinal products Biosimilar medicines Biosimilar medicines are medicines “similar” in quality, efficacy and safety to the reference biological medicines and are not subject to patent coverage. A biosimilar and its reference product, despite being the same biological substance, may have minor differences due to a certain degree of natural variability, to their complex nature and to production techniques. A biosimilar medicine is approved by the European Medicines Agency (EMA) when it has been demonstrated, through a "comparability exercise", that this natural variability and the differences compared to the reference medicine do not affect its safety and efficacy. The comparability exercise is based on a robust "head to head" comparison that proceeds by stages and according to specific standards. Any differences between the biologic medicine and its biosimilar shall not be clinically relevant. For this reason, the Italian Medicines Agency, as expressed in the second Position Paper on Biosimilar Medicines, considers biosimilars as interchangeable products with the corresponding originators (so-called "switch"), both for patients initiated for the first time to treatment (naïve) as well as for those already in therapy. Unlike what happens for equivalent medicines, it is not allowed to automatically substitute a reference biological medicine with its biosimilar nor to switch between biosimilars, therefore the pharmacist should consider the abovementioned substitution only after consultation with the prescriber. The choice of treatment remains in fact a clinical decision entrusted to the doctor and agreed with the patient who, in turn, cannot change the prescription received. If compared to their originators, biosimilars represent an additional therapeutic option and allow the treatment of a greater number of patients, so guaranteeing more health with the same resources. For these reasons it is essential to promote a constructive dialogue between doctors and patients on the therapeutic choices available, thus contributing to raising patients’ awareness and participation. In this section, AIFA provides updated information for doctors and patients with an aim to promote the appropriate use of biological and biosimilar medicines. Related documents Biosimilar medicines – Safety analysis [3.95 Mb] [PDF] > The biosimilar medicines decalogue [0.14 Mb] [PDF] > Consumption and expenditure for biosimilars - OsMed data 2018 [0.68 Mb] [PDF] > Position Paper on Biosimilars [0.77 Mb] [PDF] > Related links F. de Mora et. Al., Biosimilar and interchangeable: Inseparable scientific concepts?, BJCP, 4/09/2019 ICMRA statement about confidence in biosimilar products Biosimilari: l’ICMRA ne ribadisce vantaggi e benefici per pazienti e sistemi sanitari a livello globale FAQ - Biosimilar medicinal products European Commissione - EMA documents Intercambiabilità dei medicinali biosimilari - Comunicazione EMA sulla dichiarazione congiunta EMA-HMA - 21/09/2022 [0.1 Mb] [PDF] > Dichiarazione EMA-HMA sull'intercambiabilità dei medicinali biosimilari nell'UE - 21/09/2022 [0.1 Mb] [PDF] > Biosimilars in the EU: information guide for healthcare professionals (2019) [1.85 Mb] [PDF] > Information for patients: What I need to know about biosimilar medicines (2016) [6.7 Mb] [PDF] > Access to medicinal products Early access and off-label use Authorisation of medicinal products Medicine shortages Antibiotic medicinal products Biological medicinal products Vaccines Blood derivatives Generic medicinal products Biosimilar medicinal products Orphan medicinal products Advanced therapies Homeopathic medicinal products Allergens Medicinali di origine vegetale Ancillary medicinal substances incorporated in medical devices Share Nested Applications Highlights 21/04/2026 - Medicine Use: 2024 Regional Reports Now Available Online 17/04/2026 - From one-size-fits-all treatments to personalised care: the revolution in precision medicine TUTTE LE NEWS - IN EVIDENZA ALL NEWS News 21/04/2026 Medicine Use: 2024 Regional Reports Now Available Online 15/04/2026 AIFA updates the Transparency Lists 13/04/2026 Medicine Shortage Communication on Endoxan (ciclofosfamide) All news Nested Applications Press From one-size-fits-all treatments to personalised care: the revolution in precision medicine All press releases Last tweets 📢 #AIFA comunica il calendario degli incontri nell’ambito delle iniziative dedicate al dialogo e al... 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