ADALIMUMAB
Information current as at: 1 August 2026
PBAC meeting date: November 2026
Submission Details
- Brand name:
-
- Amgevita®
- Form and strength:
-
- Injection 20 mg in 0.2 mL pre-filled syringe
- Injection 40 mg in 0.4 mL pre-filled syringe
- Injection 40 mg in 0.4 mL pre-filled pen
- Injection 80 mg in 0.8 mL pre-filled pen
- Submission sponsor:
- AMGEN AUSTRALIA PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Immune-mediated inflammatory disease
- Listing requested:
- To request a single consolidated listing for the 100 mg per mL forms of Amgevita, as recommended by the PBAC at its March 2026 meeting. The proposed listing would align PBS subsidy more closely with TGA-approved immune-mediated inflammatory disease uses and populations and current clinical guideline recommendations for each condition. The submission also proposes simplifying restrictions, clinical eligibility criteria and continuation criteria to align with condition-specific clinical guidelines.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- Change to existing listing (–)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - November 2026 PBAC meeting
-
2Opportunity for consumer comment:
- Open 22/07/2026 and close 16/09/2026 (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 Outcome
Case ID
a1261
Page last updated
11 August 2026
v.9.19