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Ars Pharmaceutica (Internet)

versão On-line ISSN 2340-9894


RAMIREZ-TELLES, Mariana; MORA-ROMAN, Juan José  e  FALLAS-CARTIN, Milena. Marketing authorization of biologic and biotechnological products in Latin America. Ars Pharm [online]. 2021, vol.62, n.2, pp.131-143.  Epub 27-Set-2021. ISSN 2340-9894.


biological products are defined as products whose active ingredients are produced by a biological source, while biotechnological medicine is developed from the isolation of a gene of interest and its cloning.


a comparative study was carried out of the regulations in force as of July 2020 related to biological and biotechnological drugs of the countries of Central America and the Caribbean that currently have a regulatory framework for their registration, with respect to those of Chile and Brazil.


there are relevant differences in various aspects. Within the general information requested, variations were found for the definitions of Stringent Regulatory Authority, biotechnological product, reference product, and innovative product. Also, divergences were found for the non-clinical and clinical information requested and the Pharmacovigilance programs. For biosimilar products, particularities were distinguished regarding their definition and the exercise of biosimilarity, as well as for aspects of their use, such as the extrapolation of indications and automatic substitution or interchangeability. Finally, their labeling requires further study by the health regulatory authorities.


after reviewing the regulations for the marketing authorization of biological and biotechnological products in nine Latin American countries, it was found that the requested information is not homologated.

Palavras-chave : biological products; biosimilar pharmaceuticals; products registration; pharmacy legislation.

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