On December 3, 2025, Celltrion announced that the FDA has approved a new dose of OMLYCLO (omalizumab-igec), the first and only biosimilar designated as interchangeable with Genentech and Novartis’s XOLAIR (omalizumab). The FDA approved a 300 mg/2mL solution of OMLYCLO in a single-dose prefilled syringed for subcutaneous injection. Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical at Celltrion USA stated this “new dosing option of OMLYCLO can help reduce the number of required injections and ease the overall treatment burden and discomfort for patients.”
As we previously reported, Celltrion announced that the FDA approved OMLYCLO in 75 mg/0.5mL and 150 mg/mL solutions in March of 2025. 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).