Omlyclo Gains FDA Approval as Interchangeable Omalizumab Biosimilar: Daily Dose

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On March 10, 2025, we reported on the US FDA approval of Omlyclo (omalizumab-igec) as the first biosimilar to omalizumab designated as interchangeable with omalizumab (Xolair).

The approval

Omlyclo is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy, and chronic spontaneous urticaria (CSU) in patients who remain symptomatic despite antihistamine therapy.

The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global phase 3 clinical trial involving 619 adults with CSU up to Week 40. Patients were randomized to receive 300 mg or 150 mg of Omlyclo or reference product every 4 weeks. From Week 12, patients who received Omlyclo were continued on the treatment, and patients who received 300mg of the reference product were re-randomized in a 1:1 ratio to switch to Omlyclo or to continue reference product. From Week 24, patients were followed up until Week 40 without dosing. The results demonstrated the comparable efficacy and safety of Omlyclo to reference product during both treatment and off-dose periods.

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