FDA Approves Omalizumab-Igec as First Interchangeable Biosimilar to Xolair
Omalizumab-igec is approved to treat moderate to severe persistent asthma in patients 6 years and older whose symptoms are not well controlled with inhaled corticosteroids.
The FDA approved omalizumab-igec (Omlyclo) as the first interchangeable biosimilar referencing omalizumab (Xolair). This also marks the first respiratory biosimilar in the United States.1,2
The FDA issued a boxed warning for anaphylaxis based on pre- and postmarketing reports of anaphylaxis after administration. Image Credit: wladimir1804 | stock.adobe.com
Omalizumab-igec is approved to treat moderate to severe persistent asthma in patients 6 years of age and older whose symptoms are not well controlled with inhaled corticosteroids, chronic rhinosinusitis with nasal polyps for patients older than 18 years old, and food allergy for individuals aged 1 year and older to reduce allergic reactions triggered by eating 1 or more foods that the patient is allergic to. It was approved in 2 dosage forms: a 75 mg/0.5 mL injection and a 150 mg/mL injection, which can be administered via single-dose prefilled syringes subcutaneously.1,2
Adverse reactions can include injection site reactions, fever, headache, dizziness, and arthralgia. Furthermore, the FDA issued a boxed warning for anaphylaxis based on pre- and postmarketing reports of anaphylaxis after administration.1
The biologics license application for the drug, previously known as CT-P39, was based on data from a global phase 3 clinical trial (NCT04426890) that evaluated the efficacy, safety, and pharmacokinetics of CT-P39 compared to the reference product. Investigators analyzed data from the drug for patients with chronic spontaneous urticaria for up to 40 weeks, according to a company news release. The primary outcome included the equivalence of the efficacy and the potency between both drugs at 12 weeks. The secondary end point included dose response by Weekly Itch Severity Score at week 8 and week 24, Urticaria Activity Score at week 8, 12, and 24, Hives Severity Score at week 8, 12, and 24, pharmacokinetics, quality of life, and safety, including adverse events.3,4
Investigators of the study found that there was equivalent efficacy between the drugs as well as comparable safety. There were 619 patients, with 204 receiving the biosimilar in the 300 mg dosage, 205 receiving the reference product in the 300 mg dosage, 107 receiving the biosimilar in the 150 mg dosage, and 103 receiving the reference product in the 150 mg dosage.5
The mean change between the 300 mg products was evident for ISS7 at 12 weeks (treatment difference 0.77, 95% CI -0.37 to 1.90; US analysis: treatment difference 0.70, 90% CI -0.22 to 1.63). The trial also had comparable efficacy between the groups at both dose levels, with no impacts on switching. For safety, the adverse events were also comparable, according to the study authors.5
This approval comes after the biosimilar’s approval in Canada, which came in December 2024. Like most biosimilars, this marks a cost-effective option for these patient populations.2
