Biosimilars are an increasingly important part of Australian pharmacy practice, yet uptake remains well below international benchmarks—around 36% compared with an OECD average of 67%—despite a regulatory and PBS framework that supports pharmacist‑led substitution.¹⁻² This module addresses that gap by focusing on the practical realities of biosimilar use in community pharmacy, including regulatory requirements, dispensing workflows, and common operational barriers, while strengthening pharmacist capability in patient counselling and prescriber communication—key factors that influence patient confidence, acceptance, and the success of biosimilar substitution in practice.

Learning Outcomes

1. Describe biosimilars and the Australian regulatory and PBS framework for substitution.
2. Identify key a‑flagged biologics and the pharmacist’s role in supporting their use.
3. Interpret PBS authority warnings and apply a safe, compliant dispensing process.
4. Describe strategies to build prescriber relationships and communicate substitution decisions clearly.
5. Outline key counselling points for patients regarding biosimilar switching using evidence-based approaches.

PSA Accreditation

Accreditation code: PSAX26027
CPD credits: Up to 2 Group 2 credits 
Expiry date: 29/07/2028
Competency Standards (2016): 1.3, 1.4, 1.5, 2.1, 2.2, 2.3, 3.1, 3.2, 3.5

References

1. OECD (2023) Health at a Glance 2023: OECD Indicators. OECD Publishing, Paris. https://doi.org/10.1787/7a7afb35-en
2. Australian Government Department of Health and Aged Care (2024) PBS Expenditure and Prescriptions Report: 1 July 2023 to 30 June 2024. Available at: https://www.pbs.gov.au/info/statistics/expenditure-prescriptions