Abstract
Introduction: Establishing benchmarks is essential to ensure quality, efficacy, and safety while aligning with international standards. The development of a national reference model may strengthen the competitiveness of the Brazilian pharmaceutical industry and ensure access to safe and effective therapies. Objective: To analyze international benchmarks applicable to biopharmaceuticals marketed in Brazil, including innovative biologics, biosimilars, and biobetters, and to propose a national model aligned with global best practices. Methods: A systematic review was conducted on international benchmarks applicable to biopharmaceuticals marketed in Brazil. The analysis followed the PRISMA guidelines and included searches in PubMed and Scopus. As complementary sources, LILACS, Google Scholar, and official Brazilian government data were also consulted. The DOIs of the screened articles were processed using VOSviewer software to generate network maps exploring citations among countries, documents, authors, and highly recurrent concepts. Risk of bias assessment followed the JBI EvidenceBased Practice Database guidelines for Systematic Reviews and Economic Evaluations. Results: Eightyeight articles were included. The analysis revealed trends in the use of biopharmaceuticals, highlighting the growing adoption of biosimilars in chronic diseases and cancer, expanding access, reducing costs, and generating savings for health systems. Despite their economic and therapeutic benefits, biosimilar adoption faces barriers such as resistance from physicians and patients, regulatory gaps, and logistical challenges. Studies indicate the need for longterm evaluations, incentive policies, educational programs, and effective pharmacovigilance systems. Leading countries, including the United States, the European Union, the United Kingdom, and Brazil, account for most research, emphasizing regulation, safety, and market issues. In Brazil, dependence on imported inputs, limited domestic production, and a regulatory model that, although predictable, restricts competitiveness remain major challenges. Most biopharmaceuticals are imported, increasing public expenditure, particularly in oncology. The introduction of biosimilars into SUS has reduced costs but still requires regulatory updates, robust economic criteria, and strengthened domestic production to reduce external dependence. Investments in Productive Development Partnerships (PDPs) and biotechnology are strategic for expanding access and fostering innovation. Coldchain infrastructure, professional training, and educational campaigns are crucial to overcoming logistical barriers and clinical hesitancy. International experience demonstrates that regulatory harmonization, tax incentives, and tiered pricing systems improve access and stimulate competition. A national benchmark model is proposed based on regulated interchangeability, progressive pricing, and structured economic evaluations to ensure predictability, cost reduction, and competitiveness, strengthening the Health EconomicIndustrial Complex and promoting sustainability in the sector. Conclusions: Developing a model tailored to the Brazilian context may optimize the incorporation of biopharmaceuticals, reduce costs, expand access to biological therapies, and promote domestic production.
