OMLYCLO

What it is

OMLYCLO is a biosimilar medicine to Xolair (omalizumab). Omalizumab is a recombinant DNA-derived humanised monoclonal antibody produced in Chinese hamster ovary cells that selectively binds to human immunoglobulin E (IgE). OMLYCLO is supplied as solution for injection in pre-filled syringes containing either 75 mg or 150 mg of omalizumab. It is also available as solution for injection in pre-filled pens containing either 75 mg or 150 mg of omalizumab.

Approved indications

— Children 6 to less than 12 years of age with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids and who have immunoglobulin E levels corresponding to the recommended dose range. — Adults and adolescents 12 years of age and older with moderate to severe allergic asthma who are already being treated with inhaled steroids and who have serum immunoglobulin E levels corresponding to the recommended dose range. — Adults 18 years of age and above with severe chronic rhinosinusitis with nasal polyps with inadequate response to intranasal corticosteroids. — Adults and adolescents 12 years of age and above with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

Dosing overview

OMLYCLO is administered subcutaneously every two or four weeks according to a dose determination chart, with doses and dosing frequency determined by baseline serum total IgE level measured before the start of treatment and body weight. Based on IgE level and body weight measurements, 75 to 600 mg of OMLYCLO in 1 to 4 injections may be needed for each administration. For chronic spontaneous urticaria, the recommended dose is 300 mg by subcutaneous injection every four weeks, although some patients may achieve control of their symptoms with a dose of 150 mg every four weeks. In treatment for allergic asthma, at least 16 weeks of treatment is required to adequately assess whether or not a patient is responding to OMLYCLO. OMLYCLO is for subcutaneous administration only and must not be administered by the intravenous or intramuscular route. Doses of more than 150 mg should be divided across two or more injection sites.

Key safety warnings

As with any protein, local or systemic allergic reactions including anaphylaxis may occur. Anaphylactic reactions were rare in clinical trials. In post-marketing experience, anaphylaxis and anaphylactoid reactions have been reported following the first and subsequent administrations of omalizumab, with most of these reactions occurring within 2 hours after administration, some beyond 2 hours and even beyond 24 hours after injections. Patients with a known history of anaphylaxis should have each dose of omalizumab administered in a setting where treatment for anaphylaxis is available. Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of omalizumab therapy in allergic asthma or chronic rhinosinusitis with nasal polyps is not recommended. Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually. Patients with severe asthma may rarely present systemic hypereosinophilic syndrome or allergic eosinophilic granulomatous vasculitis (Churg-Strauss syndrome). In rare cases, patients on therapy with anti-asthma agents including omalizumab may present or develop systemic eosinophilia and vasculitis. A causal association between omalizumab and these underlying conditions has not been established. These events are commonly associated with the reduction of oral corticosteroid therapy. Physicians should be alert to the development of marked eosinophilia, vasculitic rash, worsening pulmonary symptoms, paranasal sinus abnormalities, cardiac complications and/or neuropathy. Discontinuation of omalizumab should be considered in all severe cases with the above-mentioned immune system disorders. Although no omalizumab-related thrombocytopenia has been observed in clinical trials, it has been reported in the post-market setting. Omalizumab should be used with caution in patients with thrombocytopenia and patients with a history of thrombocytopenia. It is recommended that patients have a platelet count before commencing therapy with omalizumab and then periodically during treatment.

Contraindications

Hypersensitivity to omalizumab or any other component of the formulation.

PBS listing

OMLYCLO is listed on the PBS as injection 150 mg in 1 mL single dose pre-filled syringe (20 items, authority required and streamlined restriction, ex-manufacturer price A$209.07) and as injection 75 mg in 0.5 mL single dose pre-filled syringe (4 items, streamlined restriction, ex-manufacturer price A$104.54), with the latest schedule dated 2026-05-01.

Regulatory history

OMLYCLO was first registered on the ARTG on 2024-11-26 for the 75 mg and 150 mg pre-filled syringe strengths, and on 2025-08-04 for the 75 mg and 150 mg pre-filled pen strengths. The AusPAR approval date was 2024-11-21. The TGA registered OMLYCLO (omalizumab) for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria based on a review of quality, safety and efficacy. The clinical development program demonstrated therapeutic equivalence for efficacy in chronic spontaneous urticaria, with pharmacokinetic and pharmacodynamic parameters similar between OMLYCLO and the reference product Xolair. No clinically important differences in the safety or immunogenicity profile were observed between OMLYCLO and Xolair.