USTEKINUMAB
Information current as at: 1 July 2026
The pharmaceutical company has not advised whether they intend to proceed or not within 60 days of receiving the ratified PBAC minutes. The process for listing is considered inactive.
Submission Details
- Brand name:
-
- Ardelya®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- SANDOZ PTY LTD
- Condition/indication:
(therapeutic use) -
- Severe chronic plaque psoriasis Severe psoriatic arthritis
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- New listing (Category 3)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
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 listing of a new ustekinumab biosimilar (Ardelya®) in 45 mg and
90 mg pre-filled syringe (PFS) forms for the treatment of adult patients with severe
chronic plaque psoriasis and severe psoriatic arthritis on a cost-minimisation basis
and under the same conditions as its reference biologic (Stelara®). The PBAC advised
the equi-effective doses to be 1 mg Ardelya = 1 mg Stelara.
The PBAC noted the sponsor’s request that the authority levels for Ardelya should
be consistent with those for Steqeyma (the first ustekinumab biosimilar to be listed
on the PBS), which aligns with the biosimilar uptake driver policy. The PBAC also
noted that the submission requested the addition of administrative advice reflecting
the biosimilar uptake driver that encourages biosimilar prescribing for treatment-naïve
patients (which already exists in the listings). The PBAC considered that the application
of both biosimilar uptake drivers to Ardelya would be clinically appropriate.