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Steqeyma (Ustekinumab)
Australian Prescription Medicine Decision Summary
Published
Product name
Steqeyma
Active ingredient
Ustekinumab
Submission type
New chemical entity - Type A application
Decision
Approved for entry in the Australian Register of Therapeutic Goods (ARTG)
Decision date
Registration date
What this medicine was approved for
Steqeyma (ustekinumab) was approved for the following therapeutic uses.
Plaque Psoriasis
Adults - Steqeyma is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Paediatric population, 6 years and older - Steqeyma is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age (60kg and over) who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriatic Arthritis (PsA)
Steqeyma, alone or in combination with methotrexate, is indicated for the 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.
Crohn’s Disease
Steqeyma is indicated for the treatment of 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.
Ulcerative Colitis
Steqeyma is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
How this medicine works
Steqeyma is a biological medicine used to treat several inflammatory conditions, including moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease. Steqeyma belongs to a group of medicines called immunosuppressants, which work by weakening part of the immune system.
Steqeyma (ustekinumab) is a biosimilar medicine to Stelara® (ustekinumab). Ustekinumab, the active substance in Steqeyma, is a human monoclonal antibody. It targets and binds to two specific proteins in the immune system: interleukin-12 (IL-12) and interleukin-23 (IL-23). These proteins play a crucial role in the inflammatory process.
Why the TGA approved or did not approve this medicine
The decision to approve steqeyma was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor.
The benefit-risk profile of Steqeyma was considered favourable for the approved therapeutic uses.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlinks below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlinks below.
ARTG details
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.