UstekinumabSTELARA
Treatment of adult patients with severe chronic plaque psoriasis and severe psoriatic arthritis.
Decisions on record
The committee reached more than one outcome for this medicine at its most recent sitting — different indications were decided differently. The header reflects the least favourable of them; all are listed below.
- Meeting Mar 2026 Recommended Severe chronic plaque psoriasis, severe psoriatic arthritis
- Meeting Mar 2026 Noted Psoriatic arthritis, chronic plaque psoriasis, Crohn disease, ulcerative colitis, complex refractory fistulising Crohn disease
- Meeting Mar 2026 Noted Psoriatic arthritis, chronic plaque psoriasis, Crohn disease, ulcerative colitis, complex refractory fistulising Crohn disease
- Meeting Mar 2025 Recommended Severe chronic plaque psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis
- Meeting Nov 2024 Recommended Severe chronic plaque psoriasis; severe psoriatic arthritis; severe Crohn disease; complex refractory fistulising Crohn disease; moderate to severe ulcerative colitis
- Meeting Jul 2024 Noted Crohn disease, severe chronic plaque psoriasis no PSD
- Meeting Mar 2024 Recommended Psoriatic arthritis, Crohn disease, chronic plaque psoriasis, ulcerative colitis, fistulising Crohn disease
- Meeting Mar 2024 Recommended Psoriatic arthritis, Crohn disease, chronic plaque psoriasis, ulcerative colitis, fistulising Crohn disease
11 earlier decisions
- Jul 2023 Recommended Fistulising Crohn disease (CD)
- Jul 2022 Recommended Moderate to severe ulcerative colitis in patients contraindicated or not responsive to conventional therapies
- Jul 2022 Recommended Severe Crohn disease, severe chronic plaque psoriasis
- Mar 2021 Recommended Paediatric severe chronic plaque psoriasis
- Mar 2017 Recommended Crohn disease
- Nov 2015 Recommended Psoriatic arthritis
- Jul 2015 Deferred Psoriatic arthritis
- Nov 2014 Not recommended 45 mg/0.5 mL injection, 1 x 0.5mL vial Stelara® Janssen-Cilag Pty Ltd Change to listing (Major submission) Psoriatic arthritis Authority Required listing for the treatment of patients with severe active psoriatic arthritis who meet certain criteria. Sponsor Comment: The sponsor had no comment.
- Jul 2014 Deferred Janssen-Cilag Pty Ltd Change to listings (Minor submission) Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis, Crohn disease, ulcerative colitis Change to the second and subsequent continuing treatment authorities for golimumab, infliximab, and ustekinumab f
- Jul 2012 Recommended Psoriasis no PSD
- Nov 2009 Recommended Chronic plaque psoriasis
Access path
- TGA registered · STELARA
TGA label equal than the PBS population
- Nov 2009Recommended · restricted
vs etanercept 50 mg/week
- Nov 2014Not recommended
Inferior joint response rate compared to TNF-α inhibitors (adalimumab), particularly lower ACR50 response rates despite…
- Jul 2015Deferred
Comparator changed: adalimumab → adalimumab; certolizumab pegol
- Nov 2015Recommended · restricted
Comparator changed: adalimumab; certolizumab pegol → certolizumab
- Mar 2017Recommended
Comparator changed: certolizumab → adalimumab (ADA), infliximab (IFX), vedolizumab (VDZ)
- Mar 2021Recommended
Comparator changed: adalimumab (ADA), infliximab (IFX), vedolizumab (VDZ) → etanercept
- Jul 2022Recommended
Comparator changed: etanercept → ustekinumab 45 mg vial (and other bDMARDs including…
- Jul 2022Recommended · restricted
Comparator changed: etanercept → ustekinumab 45 mg vial (and other bDMARDs including…
- Jul 2023Recommended · restricted
Comparator changed: vedolizumab → infliximab (IFX)
- Mar 2024Recommended
Comparator changed: infliximab (IFX) → UST 45 mg vial (for 45 mg PFS/PFP); UST 45 mg vial…
- Mar 2024Recommended
Comparator changed: infliximab (IFX) → UST 45 mg vial (for 45 mg PFS/PFP); UST 45 mg vial…
- Nov 2024Recommended
Comparator changed: Stelara (ustekinumab reference biologic) → Stelara (reference…
- Mar 2025Recommended · restricted
Comparator changed: Stelara (reference ustekinumab biologic) → Stelara (ustekinumab…
- Mar 2026Recommended
Comparator changed: Stelara (ustekinumab reference biologic) → Stelara (reference…
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended General Schedule and Section 100 (Highly Specialised Drugs Program) listings of a new biosimilar brand of ustekinumab (Epyztek®) in the following forms and under the same circumstances as the PBS-listed reference biologic, Stelara®, for the same indications: Injection 45 mg in 0.5 mL in 0.5 mg pre-filled syringe (PFS) Injection 90 mg in 1 mL PFS Solution for I.V. infusion 130 mg in 26 mLPSD · Mar 2025
5.2 The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of Epyztek would be acceptable if it were cost- minimised to Stelara at the effective price.PSD · Mar 2025
5.10 The submission presented a cost-minimisation analysis of Steqeyma compared with Stelara. The submission stated that Steqeyma will directly substitute on a mg-to-mg basis to Stelara.PSD · Nov 2024
5.11 The submission proposed that the price of the 45 mg PFS and 130 mg vial forms of Steqeyma be calculated on a cost-minimisation basis against the 45 mg and 130 mg vial forms of Stelara, respectively.PSD · Nov 2024
5.9 The submission claimed that Steqeyma is non-inferior in terms of efficacy and superior in terms of safety compared to Stelara. The submission’s claim of superior safety was made based on its latex-free formulation. PBAC considered that the claim of non- inferior comparative effectiveness was reasonable.PSD · Nov 2024
4.2 The PBAC noted and welcomed the input from the Australasian College of Dermatologists (ACD) via the Consumer Comments facility on the PBS website. ACD supported the PBS listing of Epyztek, particularly for the management of plaque psoriasis and psoriatic arthritis (in patients who are not responsive to other treatments), and considered that the availability of Epyztek may improve patient access to ustekinumab. Clinical evidencePSD · Mar 2025
4.3 As per the Product Information, the TGA has confirmed that “Epyztek is a biosimilar medicine to Stelara (ustekinumab). The evidence for comparability supports the use of Epyztek for the listed indication.”PSD · Mar 2025
6.67 The PBAC considered that a Risk Sharing Arrangement, based on the PSCR estimates with a rebate of '''''''% above the subsidy caps, would be needed to manage the risk that the market may grow beyond the estimates presented.PSD · Mar 2021
Cost-effectiveness
Cost-minimisation basis; no ICER calculated as this is a biosimilar submission with equivalent clinical efficacy to the reference product.
The PBAC noted this submission is not eligible for an Independent Review as it received a positive recommendation. PBAC · 2026
Decision context
PopulationAdult patients with severe chronic plaque psoriasis (facial, hand, foot, or whole body distribution) and severe psoriatic arthritis.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended | Stelara (reference biologic) | — | Cost-minimisation |
| Mar 2025 | Recommended · restricted | Stelara (ustekinumab reference biologic) | — | Other |
| Nov 2024 | Recommended | Stelara (reference ustekinumab biologic) | — | Cost-minimisation · Cost-minimisation |
| Mar 2024 | Recommended | UST 45 mg vial (for 45 mg PFS/PFP); UST 45 mg vial x2 (for 90 mg PFS/PFP in CPP and CD); UST 90 mg PFS (for 90 mg PFP in | — | Cost-minimisation · Cost-minimisation |
| Mar 2024 | Recommended | Stelara (ustekinumab reference biologic) | — | Single-arm · Surrogate |
| Jul 2023 | Recommended · restricted | infliximab (IFX) | — | RCT · Fistula response and fistula remission |
| Jul 2022 | Recommended | ustekinumab 45 mg vial (and other bDMARDs including adalimumab, etanercept, guselkumab, infliximab, ixekizumab, risankiz | — | Cost-minimisation · Cost-minimisation |
| Jul 2022 | Recommended · restricted | vedolizumab | — | RCT · Clinical remission |
| Mar 2021 | Recommended | etanercept | — | RCT · PASI-75 |
| Mar 2017 | Recommended | adalimumab (ADA), infliximab (IFX), vedolizumab (VDZ) | — | RCT · Clinical remission |
| Nov 2015 | Recommended · restricted | certolizumab | — | RCT · ACR50 |
| Jul 2015 | Deferred | adalimumab; certolizumab pegol | — | RCT · ACR50 |
| Nov 2014 | Not recommended | adalimumab | — | RCT · ACR50 |
| Nov 2009 | Recommended · restricted | etanercept 50 mg/week | $15k–45k | RCT · PASI-75 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CADMUS | Ph 3 | 110 | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cl… | completed |
| UNITI-1 | Ph 3 | 769 | Number of Participants With Clinical Response at Week 6 | completed |
| UNITI-2 | Ph 3 | 640 | Number of Participants With Clinical Response at Week 6 | completed |
Consumer voice
The Australasian College of Dermatologists supported PBS listing of Epyztek, particularly for plaque psoriasis and psoriatic arthritis in treatment-resistant patients, and considered that its availability would improve patient access to ustekinumab.
ACD supported the PBS listing of Epyztek, particularly for the management of plaque psoriasis and psoriatic arthritis (in patients who are not responsive to other treatments) Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC recommendation matches TGA indications exactly; both cover identical disease conditions and patient populations without additional restrictions.