ANMAT's mission is to ensure efficacy, safety and quality in everything related to administration, guaranteeing health care, as well as the quality and sanitation of all products, processes and technologies consumed or used in medicine, human cosmetics and food.

ANMAT carries out registration, control, inspection and surveillance of medicines, cosmetics, diagnostic reagents, medical products, packaged foods, dietary supplements, additives, sweeteners and ingredients, household products, disinfectants and insecticides.

Through Provision N 3397/12 of 2012, the specific requirements for the submission of applications for authorization and registration of biological drugs and/or monoclonal antibodies obtained by recombinant DNA methods are approved.

To date, ANMAT has approved four biosimilars [1] within the product classes of: 1) monoclonal antibodies; 2) anticoagulants and heparins; 3) granulocyte colony-stimulating factor (G-CSF); 4) human growth hormone for use in Argentina, see Table 1.

There are currently 19 biomimics [1] approved in Argentina that belong to the therapeutic classes of interferon, insulin, anticoagulants and heparins, erythropoiesis-stimulating agents, G-CSF, follicle-stimulating hormone (FSH), monoclonal antibodies and chorionic gonadotropin hormone, see Table 2.

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

Editor's Comments
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 ‘medicamentos biosimilares’ and ‘biomimics’ approved in Argentina 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

Similar biotherapeutic products approved and marketed in Latin America

References
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 2022 Mar 11]. Available from: www.gabionline.net/biosimilars/general/glosario-de-terminos-principales

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