USTEKINUMAB
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Steqeyma®
- Form and strength:
-
- Injection 45 mg in 0.5 mL vial
- Injection 45 mg in 0.5 mL single use pre-filled pen
- Injection 90 mg in 1 mL single use pre-filled pen
- Submission sponsor:
- CELLTRION HEALTHCARE AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Severe chronic plaque psoriasis; Severe psoriatic arthritis; Severe Crohn disease; Complex refractory fistulising Crohn disease; Moderate to severe ulcerative colitis
- Listing requested:
- To request listing of new forms of the Steqeyma biosimilar brand of ustekinumab that mirror the originator brand's current listings with equivalent forms and strengths.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required
- PBAC Submission type:
- New PBS listing (Category 4)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
5Lodgement of required documentation:
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended the listing of ustekinumab (Steqeyma®) 45 mg/0.5 mL vial, 45 mg/0.5 mL pre-filled pen and 90 mg/1 mL pre-filled pen for the treatment of severe chronic plaque psoriasis, severe psoriatic arthritis, severe Crohn disease, complex refractory fistulising Crohn disease and moderate to severe ulcerative colitis. The PBAC recommended listing on a cost-minimisation basis compared with currently listed ustekinumab products of the same strengths. The PBAC also considered that the application of biosimilar uptake drivers to Steqeyma would be clinically appropriate and would not impact cost-effectiveness
The PBAC considered that listing these additional Steqeyma presentations would provide additional biosimilar options for patients and prescribers. The PBAC recommended that the current biosimilar uptake arrangements should continue to apply for the severe chronic plaque psoriasis and severe psoriatic arthritis indications. Whilst for severe Crohn disease, complex refractory fistulising Crohn disease and moderate to severe ulcerative colitis, the PBAC considered that the new Steqeyma presentations should align with the recent December 2025 and March 2026 PBAC recommendations.
The PBAC considered it appropriate for ustekinumab pre-filled syringe and pre-filled pen presentations of the same strength to be treated as equivalent for the purposes of substitution. The PBAC also advised that the Steqeyma 45 mg/0.5 mL vial and Stelara 45 mg/0.5 mL vial should be treated as equivalent for substitution, but did not advise that vial presentations should be treated as equivalent to pre-filled syringe or pre-filled pen presentations.