In Costa Rica, the regulatory body responsible for the approval of biologicals is the Ministry of Health.
A sanitary registration is a control mechanism that entails the verification of requirements associated with the quality and safety of products of sanitary interest, with the objective of contributing to protect the health of the Costa Rican population.
Among the products that require sanitary registration for their importation, commercialization and consumption are food, cosmetics, biomedical equipment and material, medicines, pesticides for household and professional use, natural products with medicinal qualities, hygiene products, dangerous chemical products, including inks used for tattooing.
The legal framework was established in Costa Rica through the technical regulation RTCR 440:2010, Regulation on the Registration and Control of Biological Medicinal Products Nº 37006-S, which came into force on 23 September 2012.
The Ministry of Health Costa Rica defines a biosimilar as the medicine that has been demonstrated through the biosimilarity exercise, that it is similar in terms of quality, safety and efficacy to the reference biological medicine.
To date, the Ministry of Health Costa Rica has approved two biosimilars, Epoyet™ and Heberon Alfa R , within the product classes of: 1) erythropoiesis-stimulating agent; and 2) recombinant human interferon alfa, see Table 1.
| Table 1: Biosimilars approved by the Ministry of Health Costa Rica
| Product name
|| Active substance
|| Therapeutic area
|| Biosidus, Argentina
| Heberon Alfa R
|| recombinant human interferon alfa 2b
Central nervous system diseases
| Sandoz, Cuba
Data updated on 3 September 2021.
Fuente: Ministerio de Salud Costa Rica
Ior Epocim, a biomimic of erythropoietin, is also approved in Cuba for use as an erythropoiesis stimulating agent for the treatment of anaemia.
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 .
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 Costa Rica might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
The biosimilars market in Latin America: a summary
Similar biotherapeutic products approved and marketed in Latin America
LATIN AMERICAN FORUM
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LATIN AMERICAN FORUM
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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 3]. Available from: www.gabionline.net/biosimilars/general/glosario-de-terminos-principales
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Source: Ministerio de Salud Costa Rica