FDA Approves Celltrion’s Omalizumab Biosimilar

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The Center for Drug Evaluation and Research (CDER) Division of Drug Information announced on March 10, 2025 that FDA, its parent agency, had approved Omlyclo (omalizumab-igec), from South Korea-based Celltrion, as the first interchangeable biosimilar to Genentech and Novartis’ Xolair (omalizumab) (1).

Both treatments have been approved for the following indications:

• moderate to severe persistent asthma in patients aged six and older whose symptoms are not well-controlled with inhaled corticosteroids
• chronic rhinosinusitis with nasal polyps in those over the age of 18 who have had an inadequate response to nasal corticosteroids as add-on maintenance treatment
• reduction of reactions to food allergies following accidental ingestion in patients over the age of one
• chronic spontaneous urticaria, or chronic hives, formerly known as chronic idiopathic urticaria, in those aged 12 and older whose hives have continued uncontrolled by H1 antihistamine treatment (1).

Omlyclo is delivered by subcutaneous injection for treatment of all conditions listed above, but with different dosing instructions for each.

Despite the indication for reduction of allergic reactions to food, FDA said patients should avoid all foods to which they are allergic while taking Omlyclo (1). The treatment is not approved for acute bronchospasm or status asthmaticus, emergency treatment of allergic reactions (including anaphylaxis), and other forms of uticaria.

Regarding anaphylaxis, Omlyclo itself has a boxed warning for such a reaction, which can be life-threatening, based on both pre- and post-marketing reports following administration (1). Such a reaction may occur after the first dose or many doses, FDA said, and right after an injection up to days later, and is recommended to be started in a healthcare setting only.

The treatment works by binding to immunoglobulin E (IgE), which is the antibody type that triggers allergic reactions, and blocking IgE from binding to its receptors (1).

Xolair has been on the market for over two decades, having been approved in the United States in 2003. In early 2016, in its list of monoclonal antibodies to watch for that year, BioPharm International® said dupilumab—at the time in late-stage development—would likely emerge as a competitor (2). Dupilumab, developed by Sanofi and Regeneron, is now known by the brand name Dupixent.

Celltrion was previously in the news in February 2025, when the European Commission (EC) granted marketing authorization for the company’s Avtozma (CT-P47), a biosimilar referencing Roche’s RoActemra (tocilizumab), for all indications, including the treatment of moderate to severely active rheumatoid arthritis, both active systemic and polyarticular juvenile idiopathic arthritis, and giant cell arteritis (3). This followed a partnership announced in 2023 between Celltrion and fellow South Korean company Genuv for the purpose of discovering and developing novel therapeutic antibodies (4).

At the time the marketing authorization for Avtozma was granted, Celltrion reported the treatment was its 12th biosimilar approval by EC (3). Others include Vegzelma (CE-P16), a biosimilar to bevacizumab referencing Genentech’s Avastin, for the treatment of patients with metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer, announced in August 2022 (3,5).

References

1. CDER Division of Drug Information. FDA Approves First Interchangeable Biosimilar to Xolair (omalizumab). Press Release. March 10, 2025.
2. Hernandez, R. mAbs to Watch in 2016. BioPharmInternational.com, Jan. 4, 2016.
3. Celltrion. Celltrion Receives EC Approval for Avtozma (CT-P47), a Biosimilar to RoActemra (tocilizumab). Press Release. Feb. 24, 2025.
4. Mirasol, F. Genuv and Celltrion Partner on Development of Novel Therapeutic Antibodies. BioPharmInternational.com, March 17, 2023.
5. Celltrion. European Commission Approves Celltrion Healthcare’s Vegzelma (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer. Aug. 19, 2022.