AVTOZMA

What it is

AVTOZMA is tocilizumab, supplied as a concentrate solution for intravenous infusion in vials containing 80 mg, 200 mg, or 400 mg, or as a solution for subcutaneous injection containing 162 mg. AVTOZMA is a biosimilar medicine.

Approved indications

— Moderate to severe active rheumatoid arthritis in adult patients in combination with methotrexate or other non-biological disease-modifying anti-rheumatic drugs in case of inadequate response or intolerance to previous therapy with one or more DMARDs. — Moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors in combination with methotrexate in those not previously treated with methotrexate. — Moderate to severe active rheumatoid arthritis in adult patients as monotherapy in case of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate. — Giant cell arteritis in adult patients. — Moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had inadequate response to or intolerance to methotrexate. — Active systemic juvenile idiopathic arthritis in patients 2 years of age and older. — Active systemic juvenile idiopathic arthritis in patients 1 year of age and older when administered by subcutaneous injection. — Coronavirus disease 2019 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. — Chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome in adults and paediatric patients 2 years of age and older.

Dosing overview

For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended. The recommended duration of intravenous infusion is 1 hour.

Key safety warnings

During intravenous infusion and for 30 minutes post-infusion, the patient must be closely monitored for any signs or symptoms of hypersensitivity reaction. Should any such reaction occur, appropriate urgent responses and treatments are to be initiated. Equipment, treatments and protocols sufficient to initiate management of acute anaphylaxis must be in place with availability of appropriately trained personnel. For patients receiving AVTOZMA as a subcutaneous injection, at least the first injection must be performed under the supervision of a qualified healthcare professional in a healthcare facility with necessary medical treatment available, including resuscitation equipment. The patient must be closely monitored during and after the injection for any signs and symptoms of hypersensitivity reaction.

Contraindications

The provided sources do not contain information about contraindications.

PBS listing

The provided sources do not contain information about PBS listing.

Regulatory history

AVTOZMA was approved for registration on 2025-05-08. The approval decision was based on satisfactory quality, nonclinical and clinical evaluation data indicating that the benefits outweigh the risks. The TGA's quality and nonclinical evaluations found the data acceptable, and the pivotal clinical efficacy trial in rheumatoid arthritis using DAS 28-ESR as the primary outcome was deemed acceptable. AVTOZMA was first listed on the ARTG on 2025-05-30 in five variants: 162 mg/0.9 mL pre-filled pen, 80 mg/4 mL concentrated vial, 200 mg/10 mL concentrated vial, 400 mg/20 mL concentrated vial, and 162 mg/0.9 mL pre-filled syringe.