Omlyclo Becomes First Biosimilar to Rival Xolair

Genentech’s asthma drug Xolair (omalizumab) now faces its first competitive biosimilar. The FDA has approved Celltrion’s Omlyclo (omalizumab-igec) as an interchangeable product to Xolair.

Omlyclo marks Celltrion’s fourth FDA approval in barely three months this year — a significant milestone signaling the company’s rapid advancement in the biosimilar space.

Originally approved by the FDA over two decades ago for the treatment of moderate to severe persistent asthma, Xolair recently also gained approval for managing food allergies.

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The Omlyclo approval means that patients with moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E (IgE)-mediated food allergy and chronic spontaneous urticaria now have access to a treatment option that has been rigorously tested and shown to be as safe and effective as its reference product.

Omalizumab is an anti-IgE antibody that works by blocking the effects of IgE, a key driver in many allergic reactions.

Administered via injection, Omlyclo reduces symptoms by lowering the levels of free IgE in the body.

In a global Phase III clinical trial, 619 adult patients were enrolled and received either 150 mg or 300 mg of omalizumab-igec every four weeks. Patients initially on omalizumab were re-randomized to switch to omalizumab-igec or continue with their current treatment.

The trial demonstrated that the biosimilar performed comparably during both treatment and off-dose periods, reinforcing its safety and efficacy.

The trial also noted some significant side effects.

Most importantly, there is a boxed warning regarding the risk of anaphylaxis — a potentially life-threatening allergic reaction that requires immediate medical attention.

Healthcare providers are advised to administer Omlyclo in settings equipped to manage such emergencies, and patients must be closely observed after treatment.

Related: New Xolair TV Commercials Say, ‘Accidents Happen’ When It Comes to Food Allergies

Celltrion kicked off 2025 with the FDA approval of Avtozma (tocilizumab-anoh), a biosimilar to Actemra (tocilizumab), expanding treatment options for rheumatoid arthritis.

This was followed by the joint approvals of Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), referencing Prolia and Xgeva, respectively. Stoboclo treats bone disorders, including postmenopausal osteoporosis, low bone mass in men (including those on androgen deprivation therapy) and glucocorticoid-induced osteoporosis. Osenvelt is indicated for preventing skeletal-related events in multiple myeloma and bone metastases, as well as treating giant cell tumor of bone and refractory hypercalcemia of malignancy.

Industry experts are optimistic about the Omlyclo approval.

Xolair’s wholesale acquisition cost (WAC) ranges from around $1,416 per 150 mg dose to over $2,832 for a 300 mg dose. Depending on dosage and treatment indication, annual costs can range from $30,000 to $60,000.With Omlyclo’s approval, patients could potentially see reduced treatment costs, establishing broader biosimilar-driven savings.

Looking ahead, Celltrion plans to expand its R&D efforts to further enhance access to high-quality biopharmaceuticals, reaffirming its commitment to reducing the burden of chronic allergic conditions for patients across the nation.

Roche continues to advance research with Xolair, as a recent Phase III study compared it head-to-head with multi-allergen oral immunotherapy (OIT) — a treatment approach in which patients ingest small, gradually increasing doses of allergens to build tolerance. The OUtMATCH study, conducted in patients with food allergies, found that Xolair may be more effective and better tolerated than OIT.

The global biosimilars market — featuring Celltrion and other players like Amgen, Pfizer, Samsung Bioepis and Sandoz — is expected to grow to $73.03 billion by 2030.