OBJECTIVES: To compare the introduction of biosimilars in the Brazilian market and the judicialization regarding pharmaceutical assistance.

METHODS: Two studies presented before the ISPOR USA BOSTON 2023 , were compare . => A ) Analysis of the set of biological medicines after the entry of biosimilars into the Brazilian Public Health System collect from the Institute for Economic Research Foundation and from the Department of Pharmaceutical Assistance and Strategic Inputs data . And => B ) A time series study analysis of the annual spending on the general or judicialized medicines, based on the values for the period between 2007 and 2021, made available in the SIGA Brasil and SIOPS information systems. The projections of expenditure were based on the ARIMA econometric forecasting model, using the Box-Jenkins methodology. The projections of the annual budgets for Pharmaceutical Assistance was carried out based on methodology for calculating the current CA 95/2016. The inflation projection data were obtained from the Central Bank of Brazil. The analyses were performed using Gretl 1.6.5 and Microsoft Excel 10.0 software. SHOWING projections an upward trend in spending on the judicialization of medicines, generating impacts for the Pharmaceutical Assistance.

RESULTS: The analysis of the set of biological medicines showed that, on average, after the entry of biosimilars, there was a possible avoidance saving of resources around 6.0% of the CEAF budget. The projections of expenditures (2023-2025), due to the judicialization of medicines indicate an increase in the average annual impact (5.2%) on the expected total spending.

CONCLUSIONS: The comparison showed avoidance savings for biosimilars and harm in the practice of judicialization, in this scenario in Brazil. It is concluded that the use of biosimilars needs more stimuli and the practice of judicialization discourages for a better sustainability of the health system.