Posted by Michael Wonder on 25 May 2024
Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe
23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial demonstrating a comparable efficacy and safety profile with the reference product Xolair.
Celltrion today announced that the European Commission has approved Omlyclo (CT-P39), an omalizumab biosimilar referencing Xolair. Omlyclo is approved for the treatment of allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps.
