FDA Approves Celltrion’s OMLYCLO® as First Interchangeable Biosimilar to XOLAIR®

Celltrion has announced that the U.S. Food and Drug Administration (FDA) has granted approval for OMLYCLO® (omalizumab-igec) as the first interchangeable biosimilar to XOLAIR® (omalizumab). This groundbreaking approval expands treatment options for patients with moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergies, and chronic spontaneous urticaria (CSU). The designation ensures that OMLYCLO can be substituted for XOLAIR without compromising safety or effectiveness, making it a more accessible and cost-effective alternative for patients and healthcare providers.

The FDA’s decision was supported by robust clinical data, including a global Phase III study demonstrating OMLYCLO’s comparable efficacy and safety to XOLAIR. Celltrion executives emphasized the significance of this approval, with Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, stating, “This milestone not only offers a high-quality, affordable treatment option but also helps reduce healthcare costs for patients managing allergic conditions.” With this approval, Celltrion continues its commitment to providing innovative and cost-effective biologics to the U.S. healthcare market.