STEQEYMA

What it is

STEQEYMA is a biosimilar medicine to Stelara (Ustekinumab). The evidence for comparability supports the use of STEQEYMA for the listed indications. STEQEYMA is available in multiple formulations for subcutaneous or intravenous administration: 45 mg solution for injection in vial, pre-filled syringe, and pre-filled pen; 90 mg solution for injection in pre-filled syringe and pre-filled pen; and 130 mg concentrate for solution for infusion.

Approved indications

— Adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. — Children and adolescent patients from 6 years of age with moderate to severe plaque psoriasis who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. — Adult patients (18 years and older) with active psoriatic arthritis where response to previous non-biological DMARD therapy has been inadequate, alone or in combination with methotrexate. — Adult patients with moderately to severely active Crohn's disease 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. — Adult patients with moderately to severely active ulcerative colitis.

Dosing overview

**Plaque psoriasis (adults):** STEQEYMA is administered by subcutaneous injection at 45 mg 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. **Plaque psoriasis (paediatric, 6 years and older):** STEQEYMA should be administered by subcutaneous injection at weeks 0 and 4, then every 12 weeks thereafter, with the recommended dose based on body weight. For body weight less than 60 kg, the dose is 0.75 mg/kg; for 60 to 100 kg, 45 mg; and for greater than 100 kg, 90 mg. **Psoriatic arthritis:** STEQEYMA is administered by subcutaneous injection at 45 mg at weeks 0 and 4, then every 12 weeks thereafter. **Crohn's disease and ulcerative colitis:** An initial intravenous dose is administered based on body weight (260 mg for body weight ≤55 kg, 390 mg for >55 to ≤85 kg, 520 mg for >85 kg), followed by 90 mg subcutaneously 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

Key safety warnings

Ustekinumab is a selective immunosuppressant that may increase the risk of infections and reactivate latent infections, and serious bacterial, fungal, and viral infections have been observed in clinical studies. Prior to initiating treatment, patients should be evaluated for tuberculosis infection, and ustekinumab should not be given to patients with active tuberculosis; treatment of latent tuberculosis infection should be initiated prior to administering ustekinumab. Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use, with clinical presentations including cough, dyspnoea, and interstitial infiltrates; serious outcomes have included respiratory failure and prolonged hospitalisation. If diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment. Ustekinumab is a selective immunosuppressant, and 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. 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. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported in post-marketing experience, and serious infusion-related reactions including anaphylactic reactions to the infusion have been reported in the post-marketing setting. Posterior reversible encephalopathy syndrome (PRES) has been reported in clinical trials and post-marketing experience, with clinical presentation including headaches, seizures, confusion, visual disturbances and imaging changes consistent with PRES a few days to several months after ustekinumab initiation.

Contraindications

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

PBS listing

STEQEYMA 45 mg in 0.5 mL single use pre-filled syringe is listed on the PBS with streamlined and authority required restriction, with an ex-manufacturer price of A$716.69. STEQEYMA 90 mg in 1 mL single use pre-filled syringe is listed on the PBS with streamlined and authority required restriction, with an ex-manufacturer price of A$892.04.

Regulatory history

STEQEYMA ustekinumab 45 mg and 90 mg pre-filled syringes and 130 mg concentrate for infusion were first listed on the ARTG on 2024-09-11. In November 2024, the PBAC recommended listing of the new biosimilar brand under the same circumstances as the reference biologic (Stelara) for severe chronic plaque psoriasis, severe psoriatic arthritis, severe Crohn disease, complex refractory fistulising Crohn disease, and moderate to severe ulcerative colitis.