WEZLANA

What it is

WEZLANA is a biosimilar medicine to Stelara (ustekinumab). WEZLANA is available as a solution for subcutaneous injection in 45 mg and 90 mg strengths, supplied in vials, pre-filled syringes, or pre-filled pens, and as a concentrate for intravenous infusion in 130 mg strength.

Approved indications —

Moderate to severe plaque psoriasis in adults (18 years or older) who are candidates for phototherapy or systemic therapy. — Moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. — Signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological DMARD therapy has been inadequate, alone or in combination with methotrexate. — Moderately to severely active Crohn's disease in adult patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. — Moderately to severely active ulcerative colitis in adult patients.

Dosing overview

**Plaque Psoriasis** For adults, the recommended dose is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90 mg administered over Weeks 0 and 4, then every 12 weeks thereafter may be used in patients with a body weight greater than 100 kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. For paediatric patients from 6 years of age, WEZLANA should be administered at Weeks 0 and 4, then every 12 weeks thereafter. The dose is based on body weight: for patients under 60 kg, 0.75 mg/kg; for patients 60–100 kg, 45 mg; and for patients over 100 kg, 90 mg. **Psoriatic Arthritis** The recommended dose is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter. Some patients with a body weight greater than 100 kg received a 90 mg dose in clinical trials and observed a clinical benefit. **Crohn's disease and ulcerative colitis** Treatment is initiated with a single intravenous tiered dose based on body weight. Patients weighing 55 kg or less receive 260 mg (2 vials), those weighing more than 55 kg to 85 kg receive 390 mg (3 vials), and those weighing more than 85 kg receive 520 mg (4 vials). The first subcutaneous dose of 90 mg should be administered 8 weeks after the initial IV dose, then every 8 weeks thereafter. For some patients, the single IV dose followed by a 90 mg subcutaneous dose 8 weeks later, then every 12 weeks thereafter may be acceptable according to clinical judgment.

Key safety warnings

**Serious infections** WEZLANA is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections. In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients receiving ustekinumab. Prior to initiating treatment, patients should be evaluated for tuberculosis infection. WEZLANA should not be given to patients with active tuberculosis. Treatment of latent tuberculosis infection should be initiated prior to administering WEZLANA. **Non-infectious pneumonia** Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organising pneumonia have been reported during post-approval use of ustekinumab, with clinical presentations including cough, dyspnoea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalisation. **Malignancies** WEZLANA is a selective immunosuppressant and immunosuppressive agents have the potential to increase the risk of malignancy. All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer. **Hypersensitivity and infusion-related reactions** In post-marketing experience, serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Serious infusion-related reactions including anaphylactic reactions to the infusion have been reported in the post-marketing setting. **Posterior reversible encephalopathy syndrome** Two cases of PRES were reported in clinical trials, and cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab initiation.

Contraindications

WEZLANA is contraindicated in patients with severe hypersensitivity to ustekinumab or to any of the excipients. WEZLANA should not be given to patients with a clinically important, active infection.

Regulatory history

The TGA approved WEZLANA on 18 January 2024. WEZLANA was registered on the ARTG with first listing on 22 January 2024, with four variant entries covering 45 mg vials, 45 mg pre-filled syringes, 90 mg pre-filled syringes, and 130 mg intravenous infusion concentrate. The TGA's evaluation found WEZLANA to be biosimilar to Stelara based on comprehensive analytical, non-clinical, and clinical data. Studies demonstrated pharmacokinetic equivalence and similar inhibitory activity, with the clinical program including Phase I and Phase III studies supporting the biosimilarity in efficacy and safety.