From:  Biosimilars in chronic spontaneous urticaria: current evidence, clinical implications and future perspectives

 Omalizumab: regulatory timeline and approved indications [2, 25, 28].

RegionYearIndicationNotes
United States2003Moderate-to-severe allergic asthmaFirst FDA approval (≥ 12 years; later extended to younger patients)
Europe2005Moderate-to-severe allergic asthmaInitial EMA approval
Italy2006Moderate-to-severe allergic asthmaAIFA reimbursement and clinical use
Europe2014Chronic spontaneous urticaria (CSU)For patients uncontrolled with H1-antihistamines
Italy2015Chronic spontaneous urticaria (CSU)AIFA reimbursement
Europe2020Chronic rhinosinusitis with nasal polyps (CRSwNP)Add-on therapy in severe disease
United States2020Chronic rhinosinusitis with nasal polyps (CRSwNP)Similar indication to EMA
United States2024IgE-mediated food allergyReduction of risk of severe allergic reactions