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AVTOZMA (Celltrion Healthcare Australia Pty Ltd)
Product name
AVTOZMA
Date registered
Evaluation commenced
Decision date
Approval time
210 (255 working days)
Active ingredients
Tocilizumab
Registration type
New biosimilar medicine
Indication
Rheumatoid Arthritis (IV and SC formulations)
Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other nonbiological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs.
Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX.
In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate.