The US FDA has approved omalizumab-igec, a biosimilar, for the treatment of moderate to severe persistent asthma (adult and pediatric patients aged six years and older), chronic rhinosinusitis with nasal polyps (adult patients), IgE-mediated food allergy (adult and pediatric patients aged one year and older), and chronic spontaneous urticaria (adult and adolescent patients aged 12 years and above). It is the first and only biosimilar designated as interchangeable with the reference omalizumab.
Clinical evidence In a clinical trial involving 619 adult patients with chronic spontaneous urticaria, the omalizumab-igec biosimilar demonstrated comparable safety and efficacy to the reference drug, supporting the FDA’s approval and interchangeability designation. Dosage and administration Subcutaneous administration only Asthma: 75 to 375 mg every 2 or 4 weeks Chronic rhinosinusitis with nasal…
