What Australia’s Experience Reveals About Biosimilar Adoption and Pricing

Tighter health care budgets have forced payers to scrutinize how high-cost biologic medicines are financed, particularly as use continues to expand across oncology and chronic inflammatory conditions. In Australia, a combination of pricing reforms and biosimilar entry has been positioned as a way to preserve access while curbing spending growth.¹

Australia's biosimilar adoption significantly reduces biologic medicine costs, enhancing access while maintaining utilization amid tighter health care budgets. | Image credit: Anton Balazh - stock.adobe.com

A recent analysis evaluated how the introduction of biosimilars affected spending, utilization, and pricing for several widely used biologic medicines within the Australian market. Investigators conducted the study to address a persistent evidence gap: despite years of biosimilar availability, there had been limited public data quantifying how biosimilars influenced reference product prices, overall market expenditure, and volume under Australia’s Pharmaceutical Benefits Scheme (PBS).

Current State of Biosimilars in Australia

Australia’s biosimilar landscape has evolved significantly over the past decade as policymakers, regulators, and industry stakeholders have sought to balance medicines’ affordability with clinical confidence and uptake.² Regulatory approvals and pricing policies have expanded the number of biosimilars available on the Therapeutic Goods Administration’s (TGA) register and the PBS, but real-world adoption continues to lag behind other Organisation for Economic Cooperation and Development nations.

As of 2025, the TGA has approved a growing number of biosimilars across multiple therapeutic classes, including denosumab biosimilars (Stoboclo and Osenvelt), an aflibercept biosimilar (Eydenzelt), and the first natalizumab biosimilar, Tyruko.³ These approvals represent a broadening of competition into treatment areas such as osteoporosis, oncology supportive care, and neuroimmunology, beyond traditional anti-tumor necrosis factor agents.

To support uptake, the government and PBS have implemented biosimilar uptake drivers that encourage prescribers to initiate treatment with biosimilars in eligible, treatment-naïve patients.⁴ Prescribing administrative burdens have also been reduced by streamlining PBS authority requirements for biosimilar medicines, making them easier for clinicians to prescribe.

A Closer Look at Australian Data

The researchers used Australian sales data from the IQVIA MIDAS database covering both hospital and retail channels from 2010 through 2020. The analysis focused on 4 monoclonal antibodies or Fc-fusion proteins—etanercept, infliximab, rituximab, and trastuzumab—that had at least 1 biosimilar listed on the PBS for a minimum of 12 months. Outcomes included changes in total and reference product expenditure, standardized unit (SU) volume, average SU price, and biosimilar market share before and after biosimilar entry.

Across the 4 biologics, biosimilar introduction was associated with substantial spending reductions. Twelve months after biosimilars entered the market, total expenditure for reference products declined by 38.3%, while combined spending on reference and biosimilar products fell by 33.8%, even as overall use increased modestly. The authors reported that total consumption across products grew by 4.9% during the same period, suggesting that lower prices did not restrict access.

The magnitude of savings varied by molecule. Reference product expenditure fell by 55.6% for rituximab, compared with 17.9% for infliximab. By the most recent 12-month period analyzed, biosimilars accounted for nearly one-quarter of total spending across the 4 medicines, ranging from 20% for trastuzumab to 28% for rituximab.

Differences were also observed in early uptake patterns. In the first year after biosimilar entry, market share remained low for etanercept (2.0%) and infliximab (2.3%), which were among the earliest biosimilars introduced in Australia. In contrast, rituximab and trastuzumab—with more recent biosimilar launches—reached first-year market shares of 32.5% and 14.8%, respectively. Over time, these disparities narrowed. In the most recent year of data, biosimilars represented approximately 26% to 39% of total unit volume across products.

Price erosion appeared to be a key driver of savings. Average SU prices for reference products declined by 30% to 40% following biosimilar entry. For rituximab and trastuzumab, biosimilar SU prices were roughly 40% lower than those of the reference products. The authors attributed these reductions to Australia’s statutory price cuts and price disclosure policies, which require manufacturers to report sales data and trigger subsidy adjustments when competition emerges.

The analysis relied on aggregate sales data rather than patient-level information, meaning it could not estimate how many people received each medicine or assess clinical outcomes. Standardized units also did not always correspond to administered doses, particularly for oncology products such as rituximab and trastuzumab, where vial sharing and chemotherapy preparation practices may underestimate actual patient exposure. Additionally, the PBS is a dynamic system, with evolving indications, formulary changes, and clinical guidelines that may have influenced utilization trends independently of biosimilar entry.

Despite these limitations, the findings suggested that Australia’s policy framework supported meaningful price competition without mandating widespread switching. As the authors noted, “biosimilar introduction reduced overall market expenditure and [the] unit price of reference products,” creating “potential for greater medicines access for patients by reducing expenditure and releasing capital to fund more medicines.”

For managed care stakeholders, the results offered a real-world example of how coordinated pricing policies and biosimilar availability can moderate biologic spending while sustaining utilization. As biologic pipelines continue to expand, the Australian experience may provide insight into how payers can balance affordability and access without relying solely on aggressive switching mandates.

References

1. Hillen JB, Stanford T, Ward M, et al. Medicines policy in action: the impact on volume and cost of biologic medicines after biosimilar introduction. Value Health Reg Issues. 2025;50:101173. doi:10.1016/j.vhri.2025.101173

2. Australia biosimilar market size, share, trends and forecast by molecule, manufacturing type, indication, and region, 2025-2033. iMarc Group. Accessed January 15, 2026. https://www.imarcgroup.com/australia-biosimilar-market

3. Australia biosimilar approvals in early 2025. GaBi. June 5, 2025. Accessed January 15, 2026. https://gabionline.net/biosimilars/news/australia-biosimilar-approvals-in-early-2025

4. December 2023 changes to the PBS listings of medicines for the treatment of ankylosing spondylitis. PBS. December 1, 2023. Accessed January 15, 2026. https://www.pbs.gov.au/pbs/news/2023/12/1-december-2023-changes-to-the-pbs-listings-of-medicines