In Brazil, the approach of the Industrial Economic Complex of Health (Complexo Econômico-Industrial da Saúde, CEIS) has been adopted in the planning of policies related to the health economy. This involves the integration of health, industrial and innovative policies.
The articulation of public policies within the framework of the CEIS is based on the outstanding antecedent of the Unified Health System (Sistema Único de Saúde, SUS). This system was established by the Brazilian Federal Constitution in 1988, specifically in Article 196, and has been supported by subsequent laws. SUS, is a universal, public and free health system that covers approximately 75% of the population and seeks to guarantee equitable access to health services for all Brazilian citizens.
The federal government also has significant capacity for the production and acquisition of medications in the market and special conditions, which allows it to intervene in the pharmaceutical industry.
Over the first two decades of the 21st century, a set of federal policies to support and promote the Brazilian biopharmaceutical industry have been implemented, both in the research and development phase and in production. Two of the most relevant are the Industrial, Technological and Foreign Trade Policy (Política Industrial Tecnológica e de Comércio Exterior, PITCE) and the Support Programme for the Development of the Pharmaceutical Production Chain (PROFARMA) financed by the National Bank for Economic and Social Development (Banco Nacional de Desenvolvimento Econômico e Social, BNDES) among many others. Support policies have been implemented for this industry, including tax incentives, preferential credits, subsidies and technology transfer.
As a result, Brazil stands out in Latin America for its capacity for biopharmaceutical production, with numerous companies dedicated to biotechnology in the field of human health [1].
In Brazil, biological medicines consume around 40% of the federal public budget for the purchase of medicines in pharmaceutical assistance in the SUS, with rheumatoid arthritis being responsible for the highest consumption of these resources [2].
Brazil was the first Latin American country to regulate biosimilars in 2010. The first biosimilar approved by the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) was Remsima (infliximab) by Celltrion (CT-P13) in April 2015 [3].
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Recommendations for the regulation of biosimilars and their implementation in Latin America
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References
1. Amoretti L. La industria biofarmacéutica de Argentina y Brasil en el siglo XXI. Ciencia, tecnología y política. 2023;6(10):097.
2. GaBI Online - Generics and Biosimilars Initiative. Pharmaceutical market of biological and biosimilar medicines in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 18]. Available from: www.gabionline.net/reports/pharmaceutical-market-of-biological-and-biosimilar-medicines-in-brazil
3. GaBI Online - Generics and Biosimilars Initiative. Key facts of biosimilars approval regulation in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 18]. Available from: www.gabionline.net/biosimilars/general/key-facts-of-biosimilars-approval-regulation-in-brazil
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