OBJECTIVES: Rheumatoid arthritis (RA) has considerable impact on physical function and reduces quality of life. Biologics, such as etanercept, can be efficacious in reducing disease activity in their authorised indications. However, these treatment options can be very costly and present economic pressures on healthcare funding. The objective of this study was to assess budget­-impact of introducing an etanercept biosimilar in the five largest European countries (EU5). METHODS: A budget-­impact model (BIM) was developed to estimate the impact of the hypothetical introduction of an etanercept biosimilar on the healthcare budgets in EU5 over a five­-year horizon (2016­-2020) from the payer’s perspective. Prevalence-­based, incidence­based and country­-specific model adaptations evaluate the impact of introducing an etanercept biosimilar to a segment of the anti­-TNF market that includes innovator etanercept and adalimumab; comparing total costs for scenarios with and without a biosimilar. Patients naïve to biologics, on stable treatment and failing the first biologic were tracked in the model under a set of conservative assumptions: (1) uptake of 5% to 40% (2016­-2020) from etanercept to the biosimilar; (2) anti­-TNF price-­erosion of 5% per year; (3) unknown price of etanercept biosimilar – discount scenarios versus etanercept (10%, 25%) were applied. RESULTS: The theoretical introduction of an etanercept biosimilar with a 10% or 25% cost reduction versus innovator etanercept pricing, resulted in projected net budget­-savings of (millions): (1) UK €62–162, (2) France €19–46, (3) Germany €42–105, (4) Italy €26–62 and (5) Spain €16–37. Such savings, could potentially fund treatment for an additional 1,530 (UK) to 8,430 (Germany) patients with etanercept biosimilar over five-­years. CONCLUSIONS: The introduction of an etanercept biosimilar could represent substantial cost­-saving potential for healthcare systems in the EU5; budget­-impact was sensitive to market uptake­-rates and discounts versus etanercept. These savings could be used to treat additional RA patients with a biosimilar.