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Celltrion Gets FDA Nod for 300mg OMLYCLO, the First Interchangeable Xolair Biosimilar
The US FDA has approved 300 mg/2 mL prefilled syringe formulation of OMLYCLO (omalizumab-igec), expanding dosing options for patients with certain allergic diseases and supporting more personalised treatment. OMLYCLO—the first and only biosimilar interchangeable with XOLAIR (omalizumab)—previously received approval for its 75 mg and 150 mg strengths.
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) | 03/12/2025 | By Dineshwori
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