On 25 March 2026, the Australian Pharmaceutical Benefits Assessment Committee (PBAC) published the agenda for its July 2026 meeting, with three biosimilars submitted for consideration.
One of the biosimilars will be considered for the first time, Biocon’s Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), which will be supplied by its local partner Generic Health. Yesintek® has not yet received Australian marketing approval but has been approved in other regions, including Europe (February 2025), the US (February 2025) and Canada (October 2025).
Celltrion’s Steqeyma®, which was the first ustekinumab biosimilar to be PBS listed in August 2025, has been submitted for consideration by PBAC in new forms (Injection 45 mg in 0.5 mL vial, Injection 45 mg in 0.5 mL single use pre-filled pen, and Injection 90 mg in 1 mL single use pre-filled pen).
In addition, Celltrion has submitted four new indications for Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), being: branch retinal vein occlusion with macular oedema; central retinal vein occlusion with macular oedema; diabetic macular oedema; and subfoveal choroidal neovascularisation due to age-related macular degeneration. Eydenzelt® was the first aflibercept biosimilar approved in Australia in March 2025 (solely for myopic CNV). It was recommended for PBS listing in November 2025 for the same indication.
