UTEKNIX

What it is

UTEKNIX is a biosimilar medicine to Stelara (ustekinumab). The evidence for comparability supports the use of UTEKNIX for the listed indications.

Approved indications

— Treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. — Treatment of 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.

Dosing overview

For the treatment of plaque psoriasis, UTEKNIX is administered by subcutaneous injection at a recommended dose of 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 the treatment of psoriatic arthritis, UTEKNIX is administered by subcutaneous injection at a recommended dose of 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.

Key safety warnings

Ustekinumab is a selective immunosuppressant that may 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. UTEKNIX should not be given to patients with active tuberculosis, and treatment of latent tuberculosis infection should be initiated prior to administering UTEKNIX. Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab. Clinical presentations included cough, dyspnoea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. UTEKNIX is a selective immunosuppressant. Immunosuppressive agents have the potential to increase the risk of malignancy. Some patients who received ustekinumab in clinical studies developed cutaneous and non-cutaneous malignancies. In post-marketing experience, serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Serious infusion-related reactions including anaphylactic reactions have been reported in the post-marketing setting.

Contraindications

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

Regulatory history

UTEKNIX was first listed on the ARTG on 2025-02-11 as a pre-filled syringe formulation (45 mg and 90 mg strengths). The TGA approved UTEKNIX on 2025-01-20 for the treatment of adult patients with moderate to severe plaque psoriasis and active psoriatic arthritis. This decision allows UTEKNIX to be registered as a biosimilar alternative to Stelara, enhancing treatment options and supply stability.