AGEMED was created by Supreme Decree 2905 of 21 September 2016, as a decentralized unit of the Ministry of Health, with administrative, financial, legal and technical management independence, responsible for regulating the activities carried out by natural and legal, private, community, public, mixed and cooperative persons in the medicines and health technologies sector.

Until today, no biosimilar medicines have been approved in Bolivia.

Currently, three biomimics have been approved in Bolivia. These are biomimics of the monoclonal antibody rituximab, see Table 1.

  
Biomimics are intended copies, unregulated biologicals, biocopies, which cannot be considered biosimilars unless they have been reviewed and approved by the relevant regulatory agencies in accordance with the international guidelines provided by the World Health Organization (WHO) for the approval of biosimilars [2].

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘off-patent biologicals/biomimics’ approved in Bolivia might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related articles
The biosimilars market in Latin America: a summary

Biocad registers rituximab similar biotherapeutic product in Bolivia and Honduras

Similar biotherapeutic products approved and marketed in Latin America

  
Reference
1. Ortiz-Prado E, Ponce-Zea J, Vasconez JE, et al. Current trends for biosimilars in the Latin American market. Generics Biosimilars Initiative Journal (GaBI Journal). 2020;9(2):64-74. doi:10.5639/gabij.2020.0902.011
2. GaBI Online - Generics and Biosimilars Initiative. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from: www.gabionline.net/biosimilars/general/glosario-de-terminos-principales

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