Posted by Michael Wonder on 05 Dec 2025
Celltrion announces US FDA approval of 300 mg strength of Omyclo (omalizumab-igec), the first and only FDA approved interchangeable biosimilar to Xolair
1 December 2025 - Celltrion today announced the US FDA has approved a new presentation of Omyclo (omalizumab-igec), the first and only biosimilar designated as interchangeable with Xolair (omalizumab), in a 300 mg/2 mL solution in a single-dose pre-filled syringe for subcutaneous injection.
In the US, Omyclo will be marketed and distributed exclusively by Celltrion USA.
