Celltrion announced that Health Canada has approved Omlyclo, a biosimilar referencing Xolair®. Omlyclo is approved for the treatment of adults and adolescents with chronic idiopathic urticaria (CIU), also called chronic spontaneous urticaria (CSU), adult and pediatric patients with allergic asthma, and adults with chronic rhinosinusitis with nasal polyps (CRSwNP). Health Canada approved Omlyclo based on robust clinical evidence, including results from a global Phase III clinical trial designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Omlyclo compared to the reference product in patients with chronic idiopathic urticaria (CIU) up to Week 40. The results demonstrated the therapeutic equivalence between Omlyclo and reference omalizumab. About Omlyclo?
Omlyclo? is the first Health Canada approved anti-IgE antibody biosimilar referencing Xolair® (omalizumab). In Canada, Omlyclo is indicated for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (CIU) or chronic spontaneous urticaria (CSU), adult and pediatric patients (6 years of age and above) with allergic asthma, and adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Omlyclo is available as subcutaneous injections in two strengths: 75 mg/0.5 mL and 150 mg/1.0 mL.