Celltrion launches OMLYCLO, the first interchangeable biosimilar to Xolair, in the US
What's the news? Celltrion announced on 5 October 2026 that OMLYCLO (omalizumab-igec) is now commercially available in the US, making it the first and only FDA-approved interchangeable biosimilar to Xolair (omalizumab). It is offered in 75 mg/0.5 mL, 150 mg/mL and 300 mg/2 mL single-dose prefilled syringes for subcutaneous (under-the-skin) injection.
Why it matters: Omalizumab is an antibody therapy that blocks immunoglobulin E (IgE), a protein central to allergic responses; Xolair is used to treat conditions including allergic asthma and chronic hives. An "interchangeable" biosimilar can be substituted for the reference biologic at the pharmacy without a new prescription, which typically widens access and lowers cost. OMLYCLO, approved by the FDA in March 2025 and by the European Commission in May 2024, is approved for all four indications of Xolair. Its US launch extends Celltrion's biosimilar portfolio — the company launched the world's first monoclonal antibody biosimilar — into allergic disease.
