Biosimilars: Brazil should consider ways to implement regulatory data protection

Biosimilars: Brazil should consider ways to implement regulatory data protection

Journal article

1 online resource (pages 753–757)

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.

Intellectual Property Law & Practice, 20, 11, 2025.

Oxford, UK : Oxford University Press, 2025.

eng

https://academic.oup.com/pages/using-the-content/citation

External Online Journals > Journal of Intellectual Property Law and Practise