Posted by Michael Wonder on 10 Mar 2025
US FDA approves Celltrion's Omlyclo (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing Xolair
9 March 2025 - Regulatory approval for interchangeability was supported by positive Phase 3 data demonstrating comparable efficacy and safety profile with the reference product Xolair (omalizumab).
Celltrion today announced the US FDA approved Omylclo (omalizumab-igec) as the first and only biosimilar designated as interchangeable with Xolair (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, Immunoglobulin E mediated food allergy, and chronic spontaneous urticaria.
