In early 2025, Australia’s medicines regulatory agency, the Therapeutic Goods Administration (TGA), approved several biosimilars, including: Celltrion’s Stoboclo and Osenvelt (denosumab) and Eydenzelt (aflibercept), and Sandoz’s Tyruko (natalizumab).
Denosumab biosimilars: Stoboclo and Osenvelt
On 4 April 2025, the TGA approved Celltrion’s Stoboclo and Osenvelt, biosimilars to Amgen’s Prolia and Xgeva (both denosumab-based), respectively. These biosimilars are approved for the same indications as their originator products and represent the second denosumab biosimilars approved in Australia, following approval of Sandoz’s Jubbonti and Wyost in August 2024.
Stoboclo is indicated for postmenopausal osteoporosis, while Osenvelt is approved for preventing skeletal-related events in patients with bone metastases and for treating giant cell tumours of the bone [1].
Market dynamics for denosumab
In December 2024, Sandoz’s denosumab biosimilars were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS). Meanwhile, in November 2024, Amgen secured approvals for five new denosumab brands (Ganvado and Zerount, Corora, Rexadev and Deptargis), suggesting a strategy to preempt biosimilar competition by saturating the market.
Additionally, in May 2024, Amgen licensed Arrotex, a generics giant, to supply Prolia in Australia.
Natalizumab biosimilar: Tyruko
On 4 April 2025, the TGA approved Sandoz’s Tyruko, a biosimilar to Biogen’s Tysabri (natalizumab) [5], for the treatment of multiple sclerosis. This is the first biosimilar natalizumab approved in Australia.
Tyruko is available for a 300mg/15mL concentrate for infusion vial.
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) reviewed Tyruko for reimbursement in March 2025, though the outcomes remain unpublished.
Tyruko was developed by Polpharma Biologics and, under a 2019 global commercialisation agreement, Sandoz holds exclusive commercialization rights.
Tyruko is approved in Europe (September 2023) [2] and in the US (August 2023) [3].
Aflibercept biosimilar: Eydenzelt
On 31 March 2025, the TGA approved Celltrion’s Eydenzelt (CT-P42), a biosimilar to Regeneron and Bayer’s Eylea (aflibercept) for the treatment of age-related neovascular (wet) macular degeneration (nAMD), and visual impairment due to macular oedema secondary to retinal vein occlusion, diabetic macular oedema or myopic choroidal neovascularisation [3].
Eydenzelt is available in 40 mg/mL solution for intravitreal injection pre-filled syringe as well as vial with needle.
Eydenzelt is the first aflibercept biosimilar approved in Australia, following its recent approval in Europe (February 2025) [2].
Continue at: https://www.gabionline.net/biosimilars/news/australia-biosimilar-approvals-in-early-2025
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