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

Chronic spontaneous urticaria (CSU) is a debilitating condition characterized by recurrent wheals and/or angioedema lasting more than six weeks without identifiable triggers. The global prevalence is increasing, and patients with resistance to antihistamine therapies experience a significantly reduced quality of life (QoL). Omalizumab, a monoclonal anti-IgE antibody, represents the cornerstone of second-line therapy in antihistamine-refractory CSU. With the expiration of the originator patent, biosimilar versions of omalizumab are being developed and introduced, potentially improving access and reducing healthcare costs. This narrative review critically summarizes the currently available evidence on Omlyclo® (omalizumab-igec; CT-P39, Celltrion), including analytical comparability studies, regulatory evidence and the pivotal phase III clinical trial in CSU, while discussing regulatory, clinical and pharmacoeconomic implications. Available evidence supports comparable efficacy, safety and immunogenicity to reference omalizumab, although long-term real-world data remain limited. This review discusses the emerging role of omalizumab biosimilars in CSU, highlighting current evidence, remaining knowledge gaps and future perspectives.