Medicines Policy in Action: The Impact on Volume and Cost of Biologic Medicines After Biosimilar Introduction

Objectives: Rapid growth in indications and costs for biologic medicines challenges payers to balance patient access with finite health budgets. Once patents for reference products expire, introducing less expensive biosimilar medicines is one initiative to provide access to necessary medicines while maintaining the affordability of funding schemes. This study aims to describe the impact on volume and cost of biosimilars on the Australian biologics market. Methods: Australian sales data for selected biologic medicines with at least 1 biosimilar on the market for 12 months were extracted from IQVIA-MIDAS. Expenditure (USD) and volume (standardized units [SU]) were measured (2010-2020). Differences in reference product and total market expenditure, SU, and average SU price were calculated for 12 months before and after biosimilar market entry, as well as the most recent 12-month period. Results: Twelve months after biosimilar entry, total expenditure for biologic reference products was reduced by 38.3% in a market of minimal increasing use (5%). Average SU reference product price decreased by 30% to 40%, and biosimilar SU prices were up to 40% lower than reference product price. Short-term differences in biosimilar market share, were identified between earlier introduction (etanercept [2.0%] and infliximab [1.8%]) and more recent introductions (rituximab [21.8%] and trastuzumab [9.3%]). By 2020, biosimilars accounted for 30% of the biologic market. Conclusions: Biosimilar introduction reduced overall market expenditure and SU price of reference products. Sales data suggest that Australia's medicines policies create potential for greater medicines access for patients by reducing expenditure and releasing capital to fund more medicines.