Regulatory and policy landscape of biosimilars in the European Union (EU), Italy, and the United States (US).
| Aspect | EU | Italy | US |
|---|---|---|---|
| Marketing authorisation | EMA centralised (mandatory) | EMA approval valid nationally | FDA approval |
| Biosimilarity | Based on totality of the evidence | Same as EMA | Same as FDA |
| Interchangeability | Scientific principle recognized; implementation determined nationally | Physician-directed switching; no automatic substitution | Separate FDA interchangeability designation |
| Switching | Physician decision | Physician decision | Physician decision |
| Pharmacy-level substitution | Not harmonized across EU | Not permitted | Permitted only for FDA-designated interchangeable biosimilars, according to state law |
| Pricing/Access | Not centralised | Regional/National control | Market-based |
| Reimbursement | National health systems | No active AIFA monitoring registry currently required for CSU | Individual payer systems |
AS: Conceptualization, Writing—original draft. EN and CD: Conceptualization, Investigation, Supervision. MC and GWC: Validation, Writing—review & editing. All authors read and approved the submitted version.
Eustachio Nettis, who is an Editorial Board Member, and Giorgio Walter Canonica, who is Editor-in-Chief of Exploration of Asthma & Allergy, were not involved in the peer review or editorial decision-making process for this manuscript. Giorgio Walter Canonica reports having received research grants and/or lecturer or advisory board fees from A. Menarini, AstraZeneca, Celltrion, Chiesi Farmaceutici, Faes, Firma, Genentech, GrandPharma, Guidotti, GlaxoSmithKline, HAL Allergy, Novartis, OM Pharma, Organon, RedMaple, Sanofi-Genzyme, Stallergenes Greer, and Uriach Pharma. The remaining authors declare that they have no conflicts of interest.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
© The Author(s) 2026.
Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.