ADALIMUMAB
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Yuflyma®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- CELLTRION HEALTHCARE AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Moderate to severe ulcerative colitis Severe juvenile idiopathic arthritis Severe chronic plaque psoriasis Severe Crohn disease Vision-threatening non-infectious uveitis
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule PBS Section 100 Highly Specialised Drugs Program
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- Change to listing (Category 4)
- 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
-
5Lodgement of required documentation:
- 09/06/2026
-
Acceptance of complete documentation:
- Under consideration
-
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 the listing of adalimumab (Yuflyma) in the form of 20 mg in 0.2 mL pre-filled syringe (PFS) under the same circumstances as the PBS-listed reference biologic Humira 20 mg in 0.2 mL PFS and biosimilar brand Amgevita 20 mg in 0.4mL PFS. The PBAC recommended Yuflyma should also be listed for the treatment of enthesitis/spondylitis related juvenile idiopathic arthritis. The PBAC advised Yuflyma, Amgevita and Humira should be considered equivalent for the purposes of substitition (i.e. ‘a’-flagged in the Schedule).