New biosimilars to hit PBS, but uptake still lags behind

Several biosimilars are set to be listed on the Pharmaceutical Benefits Scheme (PBS), despite the nation continuing to lag behind when it comes to biosimilars uptake.

Viatris’ Nepexto has been added to the PBS from 1 July, becoming the second biosimilar to Pfizer’s Enbrel (etanercept) to be subsidised for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis. The first PBS-listed etanercept biosimilar, Brenzys by Samsung Bioepis and Arrow Pharma, was listed in April 2017.

Celltrion’s Steqeyma is set to be the first biosimilar to Janssen’s Stelara (ustekinumab) listed on the PBS, indicated for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Recommended by PBAC in December 2024 after its November meeting, Steqeyma has reached the final “government processes” stage, suggesting PBS listing is imminent.

While Amgen’s Wezlana was the first ustekinumab biosimilar recommended for PBS listing at the March 2024 PBAC meeting, the company has since withdrawn from the process and the application has ceased. Meanwhile, Samsung Bioepis’ Epyztek, also a ustekinumab biosimilar, was recommended for listing in March 2025 and remains in the early stages of the PBS process.

Another key development is Sandoz’s Tyruko, a biosimilar to Biogen’s Tysabri (natalizumab) for treating multiple sclerosis. Following its March 2025 PBAC recommendation and TGA approval in April 2025 – making it the first and only natalizumab biosimilar approved in Australia – Tyruko is also progressing toward PBS listing. Developed by Polpharma Biologics, Tyruko is commercialised globally by Sandoz under a 2019 licensing agreement.

Earlier this year, the TGA also approved Celltrion’s Eydenzelt (CT-P42), the first biosimilar to Bayer’s Eylea (aflibercept). It is indicated for age-related neovascular (wet) macular degeneration, as well as visual impairment due to macular oedema secondary to retinal vein occlusion, diabetic macular oedema, or myopic choroidal neovascularisation.

In terms of market dynamics, while OECD countries average 67% biosimilar uptake, Australia’s adoption rate for anti-TNF biosimilars is only around 36%.

The introduction of a biosimilar to the PBS triggers an automatic 25% price reduction for both the reference biologic and its biosimilar. However, unlike generic medicines where patients can benefit from lower out-of-pocket costs, PBS-listed biosimilars carry the same co-payment as the originator, removing any direct financial incentive for patients to choose a biosimilar.

Patient and clinician preference for original biologics remains a barrier to switching, particularly when the change is not clinically necessary. Common concerns include perceived inferiority, fear of adverse events, or satisfaction with current treatment. Yet, most patients are open to biosimilars – particularly in terms of new treatment initiation – if recommended by their specialist.

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