On 21 August 2026, the outcomes of the July 2026 meeting of the Australian Pharmaceutical Benefits Advisory Committee (PBAC) were published, with the following biosimilars recommended for PBS listing:
- Biocon/Generic Health’s Yesintek® (ustekinumab), biosimilar to Janssen’s Stelara®, for first time PBS listing (5 mg/0.5 mL injection, 45 mg/0.5 mL and 90 mg/1 mL pre-filled syringe (PFS) and 130 mg/26 mL solution for IV infusion). Yesintek® was approved by the TGA in each of these presentations in April 2026.
- Celltrion’s Steqeyma® (ustekinumab) for 3 new formulations (45 mg/0.5 mL vial, and 45 mg/0.5 mL and 90 mg/1 mL pre-filled pen (PFP)). Steqeyma® was the first ustekinumab biosimilar to be PBS listed on 1 August 2025 (45 mg/0.5 mL and 90 mg/1 mL PFS and 130 mg/26 mL solution for IV infusion).
- Celltrion’s Eydenzelt® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2 mg, for four additional indications: subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration (AMD), diabetic macular oedema (DMO), branch retinal vein occlusion (BRVO) with macular oedema (MO) and central retinal vein occlusion (CRVO) with MO. Eydenzelt® was the first aflibercept biosimilar approved in Australia in March 2025 (solely for myopic CNV). Although recommended for PBS listing in November 2025 for the same indication, it has not yet completed the government processes required for PBS listing.
In addition to Steqeyma®, the only other ustekinumab biosimilar currently listed on the PBS is Amgen’s Wezlana®. Wezlana® was approved by the TGA in January 2024 and was recommended by PBAC for PBS listing in April 2024, although Amgen did not proceed with the PBS listing at that time. Amgen requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting and PBAC then extended its March 2024 recommendation for a further 12 months.
Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting. Samsung Bioepis lodged documentation required for PBS listing on 10 July 2026, with the next step in the process (agreement on listing arrangements) having commenced on 14 July 2026. Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.
The only Eylea® (aflibercept) biosimilar that is PBS listed in Australia is Sandoz’s Afqlir®, which was listed in February 2026 in vial and pre-filled syringe presentations for all reference indications.