The European Commission (EC) has granted a line extension in the European Union (EU) for Celltrion's Omlyclo?? (omalizumab), Europe's first and only omalizumab biosimilar, for the 300 mg/2ml prefilled syringe (PFS). The European Commission (EC) approved Omlyclo??
75 mg/0.5ml and 150mg/1ml solution for injection in pre-filled syringe in May 2024. Omlyclo?? is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).
Xolair®? (omalizumab) is designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, omalizumab minimizes the release of mediators throughout the allergic inflammatory cascade.Omalizumab has a patient exposure surpassing 1.99 million patient-years.
Its therapeutic effect has been established for more than 20 years through numerous clinical trials and real-world studies.
