OMALIZUMAB
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Omlyclo®
- 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) -
- Uncontrolled severe asthma Uncontrolled severe allergic asthma Severe chronic spontaneous urticaria
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- 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
-
Lodgement of required documentation: - 09/06/2026
-
Acceptance of complete documentation:
- Accepted
-
6Agreement to listing arrangements:
- Commenced on 22/06/2026
-
Status:
- Under consideration
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended the listing of omalizumab 75mg and 150mg (Omlyclo®) in the pre-filled pen (PFP) form on the PBS for use in specialist settings for uncontrolled severe asthma and severe chronic spontaneous urticaria. These new PFP pen forms for the 75mg and 150mg strength can be used in the same situations as the existing Omlyclo pre-filled syringe (PFS) forms. The PBAC noted that Omlyclo is a biosimilar to the originator Xolair® and allowed substitution of the brands for one another. However, since current PBS listing of omalizumab for uncontrolled severe allergic asthma in children aged 6 to 12 years is for PFS only, the PBAC decided it would not be appropriate to link the PFP to PFS products for this age group and indication.
The PBAC considered that the listing of these new Omlyclo forms would not increase the cost to the Australian public as it is expected to replace existing Xolair or Omlyclo pre-filled syringe use.