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 ...

The approval covered two doses matching those of omalizumab -- a 75 mg/0.5 mL injection and a 150 mg/mL injection -- both to be administered in single-dose prefilled syringes for subcutaneous use.

Findings showed equivalent efficacy in change from baseline in weekly itch severity score between omalizumab-igec 300mg ... syringe for subcutaneous injection. The product should be initially ...

Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair ... Adverse events associated with Omlyclo include injection site reactions, fever, headache, dizziness and arthralgia.

SAN DIEGO -- Omalizumab (Xolair) injections outperformed oral immunotherapy (OIT) in increasing tolerance among children with ...

In this phase, all 117 participants — who were 55% male, a median age of 7 and allergic to peanuts and at least two other common food allergens (milk, egg, cashew, wheat, walnut or hazelnut) — ...

Thirty-six percent of patients treated with omalizumab were able to tolerate 2000mg of peanut protein and 2 other food allergens without experiencing an allergic reaction compared with 19% of OIT ...