OBJECTIVES: To demonstrate the impacts on prices and expenses with biological medicines of the Specialized Component of Pharmaceutical Assistance (CEAF) after the entry of biosimilars into the Brazilian Public Health System.

METHODS: Before-and-after, observational, descriptive and quantitative comparative study. Based on the time series from 2015 to 2022, a comparative analysis of the average annual prices and expenditures before and after the entry of biosimilar in the market composed of five CEAF biological medicines (Infliximab 100 mg, Adalimumab 40 mg, Etanercepte 50 mg, Rituximab 100 mg and Rituximab 500 mg) was performed. For comparison purposes, the values were updated for 2022 according to the Consumer Price Index of the Institute for Economic Research Foundation. The data were obtained from the information system of the Department of Pharmaceutical Assistance and Strategic Inputs. The analyses were performed using the Microsoft Excel 10.0 software.

RESULTS: The analysis of the set of biological medicines showed that, on average, after the entry of biosimilars, there was a saving of resources of around R$ 391,788,949.92 (29.7%) per year, about 6.0% of the CEAF budget. The entry of biosimilars of Adalimumab 40 mg provided the highest average annual impact on expenditures (-R$ 143,952,866.40), representing 36.7% of the total saved. In relation to the annual reduction in expenditures, the greatest impact occurred after the entry of biosimilars Rituximabe 100 mg (-40.1%), Rituximab 500 mg (-35.3%), Infliximab 100 mg (-35.0%), Etanercepte 50 mg (-28.2%) and Adalimumab 40 mg (-26.7%), respectively. Regarding the average annual prices, the largest decrease was observed after the intake of biosimilars of Infliximab 100 mg (-34.1%), Adalimumab 40 mg (-23.0%), Rituximab 500 mg (21.7%), Rituximab 100 mg (20.8%) and Etanercepte 50 mg (19.2%), respectively.

CONCLUSIONS: The introduction of biosimilars in the Brazilian market provided significant reductions in prices and expenses with biological medicines, dishonoring the pharmaceutical assistance budget.