Interchangeability of drugs in Peru: current outlook and future perspectives

Authors

  • Enma Perez-Chauca Unidad de Posgrado en Farmacia y Bioquímica, Facultad de Farmacia y Bioquímica, Universidad Nacional de Trujillo, Trujillo, Perú. Químico Farmacéutico, magíster en Investigación, Desarrollo e Innovación de Medicamentos http://orcid.org/0000-0003-3975-6158
  • Humberto Gomes Ferraz Facultad de Ciencias Farmacéuticas, Universidad de São Paulo, Brasil. doctor en Fármacos y Medicamentos. http://orcid.org/0000-0002-4965-4422

DOI:

https://doi.org/10.17843/rpmesp.2021.382.7322

Keywords:

Generic drugs, Therapeutic equivalency, Bioequivalence, Drug regulations, Peru

Abstract

Generic drugs play an important role in healthcare systems as they represent an effective and more affordable alternative for the population. In Peru, a regulation of interchangeability of generic drugs (also called multisource drugs) was stablished to define the procedures and requirements for developing in vivo and in vitro therapeutic equivalence studies, following the gradual application approach and sanitary risk criteria. Compliance with the new regulation will allow greater access to effective, safe and quality generic drugs. Meanwhile, drugs continue to be marketed in the absence of therapeutic equivalence studies. Findings show that some drugs failed in in vivo and in vitro comparisons with the reference product. This regulation represents a great challenge for manufacturers and holders of sanitary registrations in order to demonstrate the interchangeability of their pharmaceutical products with the reference product.

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Published

2021-07-01

Issue

Section

Special Section

How to Cite

1.
Perez-Chauca E, Gomes Ferraz H. Interchangeability of drugs in Peru: current outlook and future perspectives. Rev Peru Med Exp Salud Publica [Internet]. 2021 Jul. 1 [cited 2024 May 23];38(2):337-44. Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/7322

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