Managed Healthcare Executive March 10, 2025
Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy and chronic spontaneous urticaria.
The FDA has approved Celltrion’s biosimilar Omlyclo (omalizumab-igec), which references Xolair (omalizumab), which is marketed by Genentech and Novartis. It is approved as an interchangeable biosimilar to treat patients with moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).
Omlyclo is available as 75 mg/0.5 mL and 150 mg/mL solutions in a single-dose prefilled syringe and is interchangeable with the reference product for all indications. Omlyclo is administered subcutaneously for all indications, but it has different dose instructions for each indication.
“The interchangeability designation of Omlyclo reinforces confidence...
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