The trial randomized 619 patients in six countries to double-blind treatment with 150 or 300 mg of either omalizumab or ...

Patients were randomized to receive 300 mg or 150 mg of OMLYCLO or reference product ... has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early ...

Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis). Omlyclo was approved to treat the same conditions as Xolair. The FDA approved Celltrion’s omalizumab ...

The Food and Drug Administration (FDA) has approved Omlyclo ® (omalizumab-igec), the first interchangeable biosimilar to Xolair ® (omalizumab). Omlyclo, formerly known as CT-P39, is an ...

Successful dietary introduction was defined as consuming a median of 300 mg of protein or more each ... allergens into their diets after using omalizumab, researchers reported at the 2025 American ...

All patients were randomly assigned to receive either Omlyclo in 300 mg or 150 mg doses or Xolair every four weeks for up to 40 weeks. The study also included a switch at week 12, with patients who ...

Intake of each participant’s specific food allergen was escalated to the maintenance goal of 1,000 mg. At Week 16, participants began double-blind injection therapy, receiving either omalizumab or a ...

Patients were randomized to receive 300 mg or 150 mg of OMLYCLO or reference product every 4 ... has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as ...