AGALSIDASE ALFA, AGALSIDASE BETA
Information current as at: 1 October 2026
Submission Details
- Brand name:
-
- Replagal®
- Fabrazyme®
- Form and strength:
-
Solution for I.V. injection 3.5 mg in 3.5 mL vial
Powder for I.V. infusion, 5 mg vial
Powder for I.V. infusion, 35 mg vial - Submission sponsor:
- TAKEDA PHARMACEUTICALS AUSTRALIA PTY LTD, SANOFI AUSTRALIA AND NEW ZEALAND
- Condition/indication:
(therapeutic use) -
- Fabry disease
- Listing requested:
- For advice on whether agalsidase alfa and agalsidase beta are suitable for PBS listing for the treatment of Fabry disease under the same conditions as the PBAC’s recommendations for the PBS listing of pegunigalsidase alfa at its July 2025 meeting.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (Telephone/Online)
- PBAC Submission type:
- New listing (–)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
PBAC outcome published: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
5Lodgement of required documentation:
- Has not yet commenced
-
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 agalsidase alfa (Replagal®) and agalsidase beta (Fabrazyme®) for the treatment of Fabry disease on the PBS, following the referral from the Life Saving Drugs Program (LSDP) Expert Panel. The PBAC recommended the listings under the same conditions as it had previously recommended for pegunigalsidase alfa for the treatment of Fabry disease at its July 2025 meeting.
Case ID
1203
Page last updated
30 September 2026
v.9.19