(037) Purchases of Biological Medicines by the Ministry of Health During the Approval of Biosimilars in Brazil

Publication Number: 374

Background: The high prices of biologicals medicines have increased strain in health care budgets, especially in low-resources settings. Thus, the increase in competition with the introduction of biosimilars is expected to reduce health expenditure, improving affordability of these therapies.

Objectives: This study aims to describe the purchases of biologicals by the Ministry of Health (MH) in Brazil during the introduction of biosimilars.

Methods: This is an exploratory study examining the purchase of biologicals by the Brazilian MH in the period of 2013-2021. Data were provided by MH upon petition of the authors who requested information regarding the acquisition of monoclonal antibodies and fusion proteins procured by the federal government, excluding those acquired to attend judicial claims. The prices were adjusted according to the annual inflation in Brazil.

Results: In total, seven biological agents in 10 presentations were identified, including abatacept, adalimumab, etanercept, golimumab, infliximab, rituximab and tocilizumab. Etanercept 50 mg was the main biological with 9.9 million units purchased, followed by adalimumab 40 mg with 9.7 million units acquired. During the studied period, all the products presented price reductions. For the biologicals with biosimilars approved in the country, the prices were decreased from 85.4% (adalimumab) to 47.9% (rituximab). For the products with market exclusivity, prices reductions ranged from 68.8% (abatacept 250 mg) to 47.0% (abatacept 125 mg). Except for abatacept 250 mg and etanercept 25 mg, there was an increase in the acquisition of all other biologicals evaluated. In the case of abatacept 125 mg, the number of units purchased presented a 970.7% increase in 2021 in relation to the first acquisition in 2016.

Conclusions: Since 2013, access to monoclonal antibodies and fusion proteins have advanced in Brazil. The acquisitions by the MH raised and prices were reduced. However, comparing the purchases of biologicals with market exclusivity to those with biosimilars approved, except for adalimumab, the magnitude of price reduction observed was similar in both groups.