BIOLOGICAL PRODUCTS REGISTERED FOR MEDICAL USE IN BRAZIL, 2023–2025: REGULATORY AND THERAPEUTIC PROFILE

Abstract

Introduction: Biological products (BPs) are medicines obtained from biological systems through processes that may involve cells or microorganisms and different production technologies. Investments in this sector have been increasing, alongside the growing use of these products in the treatment of complex diseases, with monoclonal antibodies (mAbs) standing out, particularly in oncology. Objective: To characterize BPs registered in Brazil between 2023 and 2025 according to their regulatory categories, product types, therapeutic indications, and regulatory pathways, identifying the main patterns observed during the study period. Methods: A retrospective descriptive study was conducted based on data from the Brazilian Health Regulatory Agency (Anvisa). Active registrations of new medicines and new therapeutic indications were analyzed, considering regulatory categories, types of BPs, and their clinical indications. Results: During the study period, 110 active registrations of new medicines and new therapeutic indications were identified, of which 83 (75.45%) corresponded to BPs, distributed across the categories New indication (37.35%), New registration (36.14%), Biosimilar (13.25%), Expanded use (12.05%), and New pharmaceutical form (1.20%). mAbs constituted the most frequent class, followed by vaccines, enzymes, coagulation factors, peptide hormones, and fusion proteins. More than half of the new BPs were registered through the priority regulatory pathway. Conclusion: BPs accounted for the majority of medicine registrations identified in Brazil between 2023 and 2025, with mAbs, vaccines, and other biomolecules standing out. mAbs showed a broad distribution across different therapeutic areas, extending beyond oncology. Registrations of new therapeutic indications and expanded uses were also identified, including applications in different populations. These findings characterize the profile of BP registrations during the study period and demonstrate the diversity of products and therapeutic indications incorporated into the Brazilian regulatory landscape.