Study participants that received omalizumab-igec 150mg or reference ... Omlyclo is supplied as a 75mg/0.5mL and a 150mg/mL single-dose prefilled syringe for subcutaneous injection.

The approval covered two doses matching those of omalizumab -- a 75 mg/0.5 mL injection and a 150 mg/mL injection -- both to ...

The FDA has approved a new prefilled syringe formulation for Roche’s asthma drug Xolair, as the Swiss company aims to prolong its shelf life. Xolair (omalizumab) generated revenues of more than ...

Interleukin-5 prefilled syringe, autoinjector pen severe eosinophilic asthma 6 years and older Omalizumab (Xolair) IgE prefilled syringe severe allergic asthma 6 years and older Reslizumab ...

JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar ...