Biosimilars: Brazil should consider ways to implement regulatory data protection

Roberto Rodrigues, Daniela Fernandes and Dara Offrede

Journal of Intellectual Property Law and Practice, 2025, vol. 20, issue 11, 753-757

Abstract: The challenges involved in assessing the similarity of biologically active substances are well recognized.Rather than being exact copies, biosimilars can only demonstrate high comparability to the reference product. Consequently, regulatory agencies such as the Brazilian Agência Nacional de Vigilância Sanitária (Anvisa) and the European Medicines Agency have historically required biosimilar manufacturers to conduct extensive Comparative Efficacy Studies to establish biosimilarity as a prerequisite for marketing authorization.Driven by the pressing need to increase patient access to biosimilar treatments and the high costs involved in developing these medicines, the regulated sector has increasingly pushed for greater regulatory flexibility in biosimilarity assessments.

Date: 2025
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