BIMZELX

What it is

Bimekizumab is a recombinant humanized full-length monoclonal antibody of the IgG1 sub-class, expressed in a genetically engineered Chinese hamster ovary cell line. Bimekizumab is a humanised IgG1/κ monoclonal antibody with two identical antigen binding regions that bind and neutralise IL-17A, IL-17F and IL-17AF cytokines. Bimzelx is administered by subcutaneous injection. Bimzelx is available in 160 mg per 1 mL and 320 mg per 2 mL concentrations.

Approved indications —

Moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. — Active psoriatic arthritis in adult patients who have had an inadequate response to or who have been intolerant to previous disease modifying antirheumatic drug (DMARD) therapy. — Active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) in adult patients who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). — Active ankylosing spondylitis in adult patients who have responded inadequately or are intolerant to conventional therapy. — Moderate to severe hidradenitis suppurativa in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

Dosing overview

For plaque psoriasis, the recommended dose is 320 mg (given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg) at Week 0, 4, 8, 12, 16 and every 8 weeks thereafter. For psoriatic arthritis, the recommended dose is 160 mg (given as one subcutaneous injection of 160 mg) every 4 weeks. For axial spondyloarthritis, the recommended dose is 160 mg (given as one subcutaneous injection of 160 mg) every 4 weeks. For hidradenitis suppurativa, the recommended dose is 320 mg (given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg) every 4 weeks. Suitable areas for injection include thigh, abdomen and upper arm.

Key safety warnings

Bimzelx increases the risk of infections such as upper respiratory tract infections and mucocutaneous candidiasis. Caution should be exercised when considering the use of Bimzelx in patients with a chronic infection or a history of recurrent infection. Treatment with Bimzelx should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Prior to initiating treatment with Bimzelx, patients should be evaluated for TB infection. Bimzelx should not be given in patients with active TB. Anti-TB therapy should be considered prior to initiating Bimzelx in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Cases of new onset or exacerbations of inflammatory bowel disease have been reported during bimekizumab treatment. Caution should be exercised when prescribing Bimzelx to patients with inflammatory bowel disease. Patients should be monitored closely. There are higher rates of oral and oropharyngeal candidiasis in patients treated with bimekizumab consistent with the mechanism of action. Neutropenia was observed with bimekizumab in phase III clinical studies. In the 16 weeks placebo-controlled period neutropenia grade 3/4 were observed at the same frequency of 0.6% in patients receiving bimekizumab or placebo. Over the entire treatment period of Phase III studies, neutropenia grade 3/4 were observed in 1% of patients treated with bimekizumab.

Contraindications

Hypersensitivity to the active substance or to any of the excipients is a contraindication. Live vaccines should not be given in patients treated with Bimzelx.

PBS listing

Bimzelx is listed on the PBS in both 160 mg in 1 mL and 320 mg in 2 mL single use pre-filled pen formulations with authority required restriction. The ex-manufacturer price is A$3260.00.

Regulatory history

Bimzelx 160 mg in 1 mL solution for injection in both safety syringe and auto-injector devices was first listed on the ARTG on 2022-03-24. The AusPAR approval date was 2022-03-17. In March 2022, the PBAC recommended Bimzelx for severe chronic plaque psoriasis. In March 2023, the PBAC recommended Bimzelx for chronic plaque psoriasis, but in March 2024 this recommendation was rescinded. In March 2024, the PBAC recommended Bimzelx for non-radiographic axial spondyloarthritis, ankylosing spondylitis, and psoriatic arthritis. In May 2025, the PBAC recommended Bimzelx for the treatment of moderate to severe hidradenitis suppurativa. Bimzelx 320 mg in 2 mL solution for injection in both safety syringe and auto-injector devices was first listed on the ARTG on 2025-04-08. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.