CECMED carries out the basic functions of access control to laboratories, registration of medicines, diagnostics, medical equipment and devices, clinical trials, post-marketing pharmacovigilance, good practices inspections, batch releases and grant of licences.

The legal framework for the approval of biologicals is established by CECMED and according to the Resolution CECMED 70/2011, which approves and enforces Regulation 56-2011, said regulation dictates the requirements for the registration of known biological products.

To date, CECMED has approved 15 biosimilars within the product classes of: 1) endogenous growth hormone; 2) granulocyte colony-stimulating factor; 3) erythropoiesis stimulating agent; 4) insulin; 5) tumour necrosis factor (TNF)-inhibitor; 6) antiviral; and 7) interferon for use in Cuba [1], see Table 1.

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 [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 Cuba 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, Castillo D, Checa-Jaramillo DC, Rodríguez-Burneo N, Andrade F, Intriago-Baldeón DP, Galarza-Maldonado C. 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 Oct 8]. Available from: www.gabionline.net/biosimilars/general/glosario-de-terminos-principales

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