On March 7, 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Omlyclo® (omalizumab-igec) as the first interchangeable biosimilar to Novartis’ Xolair® (omalizumab). Omlyclo is approved for the same indications as Xolair, moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), immunoglobulin E (IgE)-mediated food allergy and chronic spontaneous urticaria (CSU). Because Omlyclo itself may cause anaphylaxis, the first few doses should be given by a healthcare provider in a facility staffed and equipped to manage emergencies. Currently both the cost of this biosimilar and launch date are still unknown.
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