AFLIBERCEPT
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Eydenzelt®
- Form and strength:
-
- Solution for intravitreal injection 3.6 mg in 90 microlitres (40 mg per mL) pre-filled syringe
- Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL)
- Submission sponsor:
- CELLTRION HEALTHCARE AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Branch retinal vein occlusion with macular oedema; Central retinal vein occlusion with macular oedema; Diabetic macular oedema; Subfoveal choroidal neovascularisation due to age-related macular degeneration
- Listing requested:
- To request listing of four new indications for the Eydenzelt brand of aflibercept that mirror the orginator brand's current listings. Eydenzelt was originally recommended for listing as a biosimilar brand of aflibercept at the November 2025 PBAC meeting for the subfoveal choroidal neovascularisation due to pathologic myopia indication.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required
- PBAC Submission type:
- New PBS listing (Category 3)
- 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
-
5Lodgement of required documentation:
- 18/08/2026
-
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 was in favour of extending the existing recommendation of aflibercept (Eydenzelt) 2 mg/0.05 mL vial (vial) and pre-filled syringe (PFS) for intravitreal injection.
The PBAC recommended the addition of four treatment indications under the same conditions
as the reference biologic aflibercept (Eylea):
• Subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration
(AMD)
• Diabetic macular oedema (DMO)
• Branch retinal vein occlusion (BRVO) with macular oedema (MO)
• Central retinal vein occlusion (CRVO) with macular oedema (MO)
The PBAC noted that the recommendation was on a cost-minimisation basis and the equi-effective dose is 1 mg Eydenzelt = 1 mg Eylea. The PBAC advised Eydenzelt, Eylea and Afqlir should be considered equivalent for the purposes of substitution (i.e. ‘a’-flagged in the Schedule). The PBAC noted flow-on changes to Eylea and Afqlir to include administrative advice about ‘a’-flagging.