On 22 July 2026, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) published the agenda for its November 2026 meeting, with a number of biosimilars and biopharmaceuticals to be considered for reimbursement.
New Biosimilar Listings
PBAC will consider the following applications for reimbursement of biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) for the first time: Accord Healthcare’s Denolia® and Deskleta® in 60mg/1mL pre-filled syringe (PFS), and Dexeva® and Dostiva® in 120mg/1.7mL PFS (each TGA-approved in October 2025).
Amgen’s Prolia® and Xgeva® are now sponsored in Australia by Arrotex, following a 2024 deal between the companies. Denosumab biosimilars currently listed on the Pharmaceutical Benefits Scheme (PBS) are Sandoz’s Wyost® and Jubbonti® (PBS-listed 1 August 2025), Amgen’s supplemental denosumab brands Corora® and Ganvado® (PBS-listed 1 September 2025, sponsored by Arrotex) and Celltrion’s Stoboclo® and Osenvelt® (PBS-listed 1 March 2026).
The following biosimilars to Genentech’s Lucentis® (ranibizumab) will also be considered at the November PBAC meeting:
- Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved in February 2026); and
- Generic Health’s Solentis® and Simulara® in 1.65mg/0.165mL PFS and 2.3mg/0.23mL PFS (not yet TGA-approved).
The only other approved ranibizumab biosimilar in Australia is Samsung Bioepis’ Byooviz® (approved August 2022), which is not currently PBS-listed.
Amended Biosimilar Listings
Amgen has submitted a request for a “broad listing” of Amgevita® (for the higher concentration forms recommended by PBAC at its March 2026 meeting: 20mg/0.2ml & 40mg/0.4ml PFS and 80mg/0.8ml pre-filled pen (PFP)) for the treatment of immune-mediated inflammatory disease.
Originator Biopharmaceuticals
MSD is requesting PBS listing of a new subcutaneous form of Keytruda® (pembrolizumab) (in two different strengths) under the same circumstances and for the same indications as the currently listed intravenous form. The TGA approved both strengths of Keytruda SC™ (395mg/2.4mL and 790mg/4.8mL) on 23 July 2026.
Roche has resubmitted its request to list Susvimo® (ranibizumab), a solution for ocular implant (39.5mg/0.395mL), for the treatment of wet AMD. This follows the PBAC’s decision against recommending PBS-listing of Susvimo® at its May 2026 meeting, on the basis that Roche was seeking TGA approval for an updated version of the port delivery system for the medicine.
Bayer has submitted a request to list high dose Eylea® (aflibercept, 8mg) in 114.3mg/mL intravitreal injection for the treatment of visual impairment due to macular oedema following branch or central retinal vein occlusion (RVO). Eylea® 8mg has been PBS-listed for nAMD and diabetic macular oedema since 1 November 2024.
Dr Reddy’s Laboratories has submitted a request to list a new indication of Zytorvi® (toripalimab) in 240mg/6mL solution for IV infusion, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC). Zytorvi® was first listed on the PBS on 1 December 2025 for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma.