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Four Celltrion Biosimilars on November PBAC Agenda in AU

Jul 30, 2025

On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered:

  • Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg), for all reference indications;
  • Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), for all reference indications; and
  • Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for all reference indications.

Biosimilar aflibercept

Celltrion’s Eydenzelt® (approved March 2025) is the second aflibercept biosimilar to be considered by PBAC, following Sandoz’s aflibercept biosimilars Afqlir® and Enzeevu™, which were approved in May 2025 and considered by PBAC in July 2025.  The outcomes of the July 2025 meeting have not yet been published.  Beyond those of Sandoz and Celltrion, there are no other aflibercept biosimilars approved in Australia.

Biosimilar denosumab

In December 2024, Sandoz’s denosumab biosimilars, Jubbonti® and Wyost®, were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).  Jubbonti® and Wyost® were the first denosumab biosimilars approved in August 2024, followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).  In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia.  In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

Biosimilar tocilizumab

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and to be considered for PBS-listing.  In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence™ in June 2024.

Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025), trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).