The adoption of biosimilars, biological drugs similar to reference medications, has emerged as a pivotal strategy for reducing healthcare costs while maintaining efficacy and safety. A review by Azevedo, VF, et al.examines how Unimed Maringá, a private healthcare provider in Brazil, implemented a biosimilar management programme, achieving significant cost savings and broader patient access to essential therapies [1].
Biological drugs have revolutionized the treatment of autoimmune diseases, oncology, and other conditions, but their high costs present substantial challenges for healthcare systems. Biosimilars offer a solution by providing equivalent safety and efficacy at reduced costs, fostering competition, and expanding treatment access. In resource-constrained environments like Brazil, their adoption is particularly important for addressing health disparities and rising expenditures.
Unimed Maringá adopted a three-pronged approach to integrate biosimilars into its system in 2023. This included continuous education for healthcare professionals, disease-specific protocols to guide patient selection, and transparent procurement strategies. The initiative aimed to ensure a smooth transition from reference drugs to biosimilars, addressing potential concerns from patients, physicians, and other stakeholders.
The results of this strategy were remarkable. Between September and December 2023, switching 44 patients to biosimilars led to a 55.9% reduction in treatment costs. Overall, Unimed Maringá achieved savings of R$ 708,995.78 for 63 autoimmune patients during this period. These savings not only reduced financial strain but also enhanced treatment access and improved supply chain resilience.
According to one of the study authors, Associate Professor Valderilio Azevedo, MD, PhD, MSc, a rheumatologist and president-elect of the Brazilian Society of Rheumatology (SBR), this is the first cost-minimization study involving biosimilars in Brazil, making a groundbreaking achievement in pharmacoeconomics. He emphasized the ‘magnificent, well-articulated work, carried out by Unimed of Maringá-PR,’ which adhered to ideal guidelines for managing switches between reference products and biosimilars. The Brazilian Journal of Health Economics was commended for leading real-world studies in this field, addressing not only product switches but broader challenges such as professional education, paradigm shifts, and cultural changes in acquiring high-cost products within supplementary health
The Unimed Maringá experience highlights the transformative potential of biosimilars in creating sustainable healthcare systems. Through well-structured management strategies, healthcare providers can achieve significant economic benefits while ensuring high-quality care and broader treatment access. This model offers valuable insights for systems worldwide seeking to optimize costs and outcomes [1].
In Brazil, a legal framework for approving follow-on biological products using a comparability pathway was established in 2010 through Resolution RDC 55/2010 [2], issued by the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA). This regulation governs the approval of biosimilars. In June 2024, Resolution RDC No. 875 was published in the Official Journal of the Union (DOU) [3], amending RDC 55/2010 regarding the registration of biological products.
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References
1. Azevedo, V., Rezende, M., Brovini, R. R., Odebrecht, P. C., Moreira, B. E., & Guadagnim, T. H. (2024). Cost minimization and switching management of reference products and their biosimilars in the Brazilian private health system: the case of Unimed Maringá. Jornal Brasileiro De Economia Da Saúde, 16(2), 80–86. https://doi.org/10.21115/JBES.v16.n2.p80-6.
2. GaBI Online - Generics and Biosimilars Initiative. Follow-on biologicals/biosimilars approved in Brazil: May 2023 update [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 21]. Available from: www.gabi-journal.net/follow-on-biologicals-biosimilars-approved-in-brazil-may-2023-update.html3.
3. GaBI Online - Generics and Biosimilars Initiative. New regulations in Brazil for the registration of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 21]. Available from: www.gabionline.net/guidelines/new-regulations-in-brazil-for-the-registration-of-biosimilars
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