Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products

Abstract

Brazil has established a framework for provision of generic pharmaceuticals including for orally inhaled and nasal drug products (OINDP) to its populace. This includes the development of guidelines or “resolutions” and normative instructions describing the Brazilian medicines agency’s (Anvisa) expectations for demonstrating OINDP therapeutic equivalence. The Anvisa regulatory framework for OINDP therapeutic equivalence, challenges, and comparisons with the US Food and Drug Administration and European Medicines Agency approaches are assessed and discussed.

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Correspondence to Lee Nagao.

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Discussion and analysis of the Anvisa (Brazil’s medicines agency) regulatory framework and emerging regulatory expectations for therapeutic equivalence of orally inhaled and nasal drug products

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Silva, M.C., Costa, H.S., Valadares, B.N. et al. Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products. AAPS PharmSciTech 20, 235 (2019). https://doi.org/10.1208/s12249-019-1415-y

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Key words

  • Anvisa
  • orally inhaled drug products
  • nasal drug products
  • therapeutic equivalence