Follow-on biologicals/biosimilars approved in Brazil: September 2025 update

Author(s): German Enrique Wassermann, PhD, Sílvia Helena Cestari de Oliveira, MSc

Abstract: In Brazil, the legal framework for approving biosimilars was established in 2010 and the first biosimilar product was approved in 2015. In June 2024, RDC 875 introduced new provisions, including the use of international reference drugs and the possibility of waiving non-clinical and comparative clinical studies under certain conditions. By September 2025, ANVISA had […]

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