USTEKINUMAB

Information current as at: 1 June 2026

PBAC meeting date: July 2026

Legend:

Completed N In progress

Not applicable N Yet to commence

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 (–)
Comment:: --
Other PBAC consideration:: --

Submission received for:: July 2026 PBAC meeting
Opportunity for consumer comment:: Open 25/03/2026 and close 20/05/2026 (see PBS Website)
3PBAC meeting:: Has not yet occurred
4PBAC outcome published:: Pending PBAC outcome (see PBAC Outcomes)
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 Recommendation:

Please see the Outcomes from the relevant meeting for more information

Case ID

1245

Page last updated

31 May 2026

v.9.19