Presentation (CTI)

OBJECTIVES: Biosimilars represent a key opportunity to improve patient access and reduce pharmaceutical expenditure in publicly funded healthcare systems. However, variation in regulatory and reimbursement frameworks can hinder their optimal uptake. In Australia, reimbursement decisions are informed by evaluations conducted by the Pharmaceutical Benefits Advisory Committee (PBAC), with recommendations published in Public Summary Documents (PSDs). This study synthesizes methodological insights from recent PBAC assessments to inform future biosimilar submissions.
METHODS: We systematically reviewed the Pharmaceutical Benefits Scheme (PBS) website to identify biosimilars recommended for PBS listing between March 2024-March 2025. Available PSDs were analyzed to extract information on submission type, evidentiary requirement (clinical and pharmacokinetic), economic justification, substitution status (‘a’ flagging, means a pharmacist can dispense the biosimilar instead of reference biologic under certain conditions), and any policy-related recommendations to encourage biosimilar uptake. A thematic synthesis was conducted to identify recurring methodological patterns.
RESULTS: Between March 2024-March 2025, PBAC recommended nine biosimilars: three for ustekinumab, two for adalimumab, and one each for denosumab, infliximab, natalizumab, and omalizumab. PSDs were available for adalimumab, denosumab, and ustekinumab. All submissions demonstrated biosimilarity primarily through pharmacokinetic comparability studies, with supplementary clinical data provided as required. PBAC accepted the use of prior data from lower-dose formulations to support higher-strength presentations where no clinically meaningful differences were anticipated. All submissions employed a cost-minimization approach, based on assumed therapeutic equivalence, with proposed prices equal to or lower than the reference biologic. Each included submission incorporated PBAC-recommended notes promoting use in treatment-naïve patients, aligning with the Australian Government’s two specific drivers to encourage the use of biosimilar medicines, which complement the Biosimilar Awareness Initiative.
CONCLUSIONS: PBAC’s recent biosimilar recommendations reflect a consistent methodological framework characterized by robust comparability data, cost-minimization, and strategic alignment with national biosimilar policies. This study offers actionable guidance for stakeholders preparing biosimilar reimbursement submissions in the Australian context.