Immune checkpoint inhibitors in Brazil: regulatory approval and public procurement within the Unified Health System

Immune checkpoint inhibitors (ICIs) represent a major advance in cancer immunotherapy, providing durable clinical responses in several malignancies. Despite their growing clinical relevance, information on regulatory approval and public procurement of ICIs in middle-income countries remains limited. In this context, the upcoming expiration of patents for several ICIs, expected from 2026 onward, may substantially impact access and pricing. This study describes the regulatory landscape and federal acquisition of ICIs in Brazil between 2014 and 2023. A retrospective descriptive analysis was conducted using publicly available databases from the Brazilian Health Regulatory Agency (ANVISA) and the Federal Government procurement system. All ICIs approved during the study period were evaluated according to molecular target (PD-1, PD-L1, CTLA-4), antibody type, expression system, approved clinical indications, number of units acquired, and acquisition costs. Nine ICIs had active marketing authorization in Brazil, eight of which were procured by the Federal Government. Nivolumab and pembrolizumab accounted for the highest number of units acquired and the largest share of total expenditure. Overall federal spending on ICIs exceeded BRL 861 million during the study period, with PD-1 inhibitors representing approximately 78% of total costs. Most units (66%) were allocated to centralized logistics centers of the Brazilian Unified Health System (SUS), while regional distribution data revealed a concentration of acquisitions in the South and Southeast regions. No ICI biosimilars were approved during the study period, despite the anticipated patent expiration of key molecules beginning in 2026. Although federal investment in ICIs has increased, access within the Brazilian public health system remains uneven, limited by high costs, centralized distribution, and the current absence of biosimilars. The forthcoming patent expirations may represent a strategic opportunity to expand access through biosimilar incorporation and local production. Strengthening regulatory strategies, improving transparency in distribution, and fostering innovation are essential to promote equitable access to cancer immunotherapy in Brazil.