On 18 December 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) November 2025 meeting were published, including recommendations for the listing of three Celltrion biosimilars on the Pharmaceutical Benefits Scheme (PBS):
- Eydezenlt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg);
- Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab); and
- Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab).
Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV). It was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025, and Samsung Bioepis’ Opuviz® on 18 September 2025, which were each approved for all reference indications. Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme, though have not yet been listed.
In December 2025, Regeneron/Bayer and Sandoz settled all Australian aflibercept patent infringement/revocation proceedings, with the terms of the settlement not otherwise being disclosed. Regeneron/Bayer are defending pending revocation proceedings commenced by Actor Pharmaceuticals in August 2025 and have cross-claimed for infringement.
In addition to Celltrion’s Stoboclo® and Osenvelt® (approved April 2025), there are three other sponsors with denosumab biosimilars approved in Australia: Sandoz’s Jubbonti® and Wyost® (August 2024), Samsung Bioepis’ Ospomyv® and Xborso® (July 2025) and Accord’s Denolia™/Deskeltia™ and Dostiva™/Dexeva™ (October 2025). On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed. In April 2025, Amgen commenced Court proceedings in Australia seeking preliminary discovery of documents from Sandoz in relation to its denosumab biosimilars. That proceeding concluded and Amgen commenced patent infringement litigation against Sandoz in the Federal Court of Australia in June 2025.
Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and to be considered (and now recommended) for PBS-listing.