Shots:
- The US FDA has approved Omlyclo, an interchangeable biosimilar version of Xolair (omalizumab), in PFS presentation (300mg/2ml, SC) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), & IgE-mediated food allergy
- Omlyclo previously received the US FDA approval in Mar 2025 for PFS injections at 75mg/0.5mL & 150mg/1mL, based on the extensive clinical evidence, showing comparable efficacy & safety between Omlyclo & the reference product
- Omalizumab is a humanized mAb that binds free IgE to reduce the release of inflammatory mediators across the allergic cascade in allergic asthma, CSU, & CRSwNP
Ref: PRNewswire | Image: Celltrion | Press Release
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