The Agency was created by the Law 9.782 of 26 February 1999. The Agency’s mission is to protect and promote public health, guaranteeing the health products’ safety and participate in building its access. The Agency is led by a Collegiate Board of Directors, composed by five members and it is executed by institutions of the direct and indirect Public Administration of the Union, the States, the Federal District and the Municipalities, that execute regulatory activities, normalization, control and inspection in the health surveillance zone.

In Brazil, the legal framework that approves the marketing of biological products and biosimilars is the Resolution 55 (of 16 December 2010).

Remsima (CT-P13), an infliximab’s biosimilar, was the first biosimilar approved by ANVISA in April 2015.

To date, ANVISA has approved 30 biosimilars [1] within the product classes of: 1) insulin; 2) monoclonal antibodies; 3) tumor necrosis factor (TNF) inhibitor; 4) human growth hormone; 5) anticoagulants and heparins; 6) granulocyte colony-stimulating factor for use in Brazil, see Table 1.

Hibor, a biomimic of bemiparin, is also authorised in Brazil for its use as an antithrombotic agent for the treatment of established venous thromboembolic disease.

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 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 ‘biosimilars’ approved in Brazil might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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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 Jan 14]. Available from: www.gabionline.net/es/biosimilares/general/glosario-de-terminos-principales

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