USTEKINUMAB
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Yesintek®
- Form and strength:
-
- Injection 45 mg in 0.5 mL
- Injection 45 mg in 0.5 mL single use pre-filled syringe
- Injection 90 mg in 1 mL single use pre-filled syringe
- Solution for I.V. infusion 130 mg in 26 mL
- Submission sponsor:
- GENERIC HEALTH 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 a new ustekinumab biosimilar that mirrors the originator brand’s current listings.
- Funding program:
- PBS General Schedule PBS Section 100 (Highly Specialised Drugs Program)
- Request authority level:
- Authority Required
- PBAC Submission type:
- New PBS listing (Category 3)
- 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
-
PBAC outcome published: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
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 General Schedule and Section 100 Highly Specialised Drugs listing of a new ustekinumab biosimilar (Yesintek®) in 45 mg injection, 45 mg and 90 mg pre-filled syringe (PFS), and solution for intravenous (I.V.) infusion 130 mg in 26 mL forms. This was for the treatment of paediatric and adult patients with severe chronic plaque psoriasis (CPP), severe psoriatic arthritis (PsA), severe Crohn’s disease (CD), complex refractory fistulising Crohn’s disease, and moderate to severe ulcerative colitis (MSUC). The proposed listing was on a cost-minimisation basis and under the same conditions as its reference biologic (Stelara®). The PBAC advised the equi-effective dose to be 1 mg Yesintek = 1 mg Stelara. The PBAC considered that the current biosimilar uptake arrangements should continue to apply for the CPP and PsA indications for Yesintek and that the application of biosimilar uptake drivers would be clinically appropriate and would not impact cost-effectiveness.
The PBAC advised that the PBAC’s December 2025 recommendation for bDMARDs would apply for the MSUC and CD indications of Yesintek. This change would apply new restrictions that support access for people who started advanced therapy during childhood. Additionally, the PBAC advised that the PBAC’s March 2026 recommendation for IBD indications would apply for Yesintek. This change would consolidate restrictions for initial and continuing treatment for CD, MSUC and fistulising CD for Yesintek.