Paving the Way for Equitable Biosimilar Access in Australian Dermatology Clinics

Improved policies to encourage biosimilar use in Australia could promote long-term sustainability for the country’s pharmaceutical benefit program and help maintain equitable access to health care across the nation, according to a report.¹

Between 2020 and 2021, when combining the costs for 8 of the 10 most expensive biologics subsidized under the Pharmaceutical Benefits Scheme (PBS) cost the Australian Government AU$2.41 billion. | Image credit: Sandor Kacso - stock.adobe.com

The report, published in the Australasian Journal of Dermatology, was created to address the growing financial burden of biologic therapies for inflammatory skin diseases in Australia.² As patents expire, biosimilars offer a cost-effective alternative.

As of May 2025, there are 16 biosimilars approved for Australian dermatologists to prescribe, including 2 infliximab, 3 etanercept, 7 adalimumab, 3 rituximab, and 1 ustekinumab.¹

Despite approvals for several dermatologic biosimilars, uptake has been limited. The report highlighted that in the US, patients may receive rebates or discounts on reference biologics, creating a financial disincentive to switch to biosimilars.³ This can hinder biosimilar uptake despite potential systemwide savings. In contrast, Australia’s Pharmaceutical Benefits Scheme (PBS) sets the same co-payment for both biologics and biosimilars, eliminating patient cost differences. While this promotes equitable access, it also means patients have little financial motivation to prefer biosimilars—placing more weight on clinician choice and system-level policies to drive uptake.

Upon market entry, biosimilars trigger a 25% price reduction for both the reference biologic and biosimilar.⁴ Continued uptake further lowers prices through competitive benchmarking. These savings, estimated at up to 24%, can be reinvested to support the PBS and broader health system sustainability.⁵ For managed care, the findings underscore biosimilars as a key tool for cost containment without compromising treatment outcomes.

According to the authors, biosimilar uptake in Australia is shaped by a combination of clinical concerns, regulatory frameworks, and patient perceptions. Clinicians, particularly in dermatology, have expressed ongoing concerns about the efficacy and safety of biosimilars, citing issues like immunogenicity, indication extrapolation, and interchangeability. These apprehensions are partly rooted in the biosimilar development process, which emphasizes preclinical analytical comparability over extensive clinical trials—a marked difference from the development of originator biologics.

While regulatory agencies like the Therapeutic Goods Administration (TGA), the Australian equivalent of the FDA, confirm no clinically meaningful differences between biosimilars and reference biologics, many clinicians remain cautious, especially regarding nonmedical switching of stable patients. Substitution policies under the PBS, such as ‘a’-flagging, allow pharmacy-level switching, but some prescribers prefer retaining decision-making authority.

Patients, too, often prefer originator biologics and may distrust biosimilars due to limited understanding and misinformation from social networks. To address these barriers, increased clinician and patient education, streamlined prescribing processes, and inclusion in treatment guidelines are critical for building confidence and encouraging broader biosimilar adoption.

The authors concluded, “Increased uptake of biosimilars has the potential to ensure the ongoing sustainability of the PBS. Collaborative efforts to improve the knowledge and attitudes of clinicians and patients alike are necessary to maximise the potential of biosimilars in Australia.”

References

1. Li GX, Marabani M, Sebaratnam DF. Biosimilars for Australian dermatologists. Australas J Dermatology. 2025;66(3):152-156. doi:10.1111/ajd.14427

2. Pharmaceutical Benefits Scheme—biosimilar rituximab. Department of Health and Aged Care. September 2022. Accessed May 13, 2025. https://www.health.gov.au/sites/default/files/documents/2022/09/biosimilar-medicine-fact-sheet-rituximab.pdf

3. Mroczek DK, Hauner K, Greene GJ, et al. Obstacles to biosimilar acceptance and uptake in oncology: a review. JAMA Oncology. 2024;10(7): 966-972. doi:10.1001/jamaoncol.2024.1447

4. ARA advice regarding the use of biosimilar DMARDs. Australian Rheumatology Association. November 12, 2023. Accessed May 13, 2025. https://rheumatology.org.au/Portals/2/Documents/Public/Professionals/Position%20Statements/241023%20ARA%20position%20statement%20biosimilars%20Nov23%20final.pdf?ver=2023-12-11-090000-277

5. Gleeson D, Townsend B, Lopert R, Lexchin J, Moir H. Financial costs associated with monopolies on biologic medicines in Australia. Aust Health Review. 2019;43(1):36-42. doi:10.1071/AH17031