On March 9, 2025, Celltrion announced that the FDA has approved OMLYCLO® (omalizumab-igec), the first and only biosimilar of XOLAIR® (omalizumab). The FDA approved OMLYCLO® with an interchangeability designation based on positive phase III data demonstrating comparable efficacy and safety profile with XOLAIR® (omalizumab), which is co-promoted by Genentech and Novartis.
OMLYCLO® is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU). Hetal Patel, Vice President of Medical Affairs at Celltrion, stated “[t]he interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between OMLYCLO and the reference product.”
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