In Cuba, the regulatory body responsible for approving biological drugs is the Center for the State Control of Medicines, Medical Equipments and Devices (Control Estatal de Medicamentos, Equipos y Dispositivos Médicos, CECMED).
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.
| Table 1: Biosimilars approved by CECMED
|
| Product name
|
Active substance
|
Therapeutic area
|
Manufacturer/
Company name
|
| Actrapid®
|
mono-competent DNA of human insulin
|
Diabetes
|
LIORAD, Novo Nordisk
|
| Betaferon®
|
recombinant interferon-β 1b
|
Multiple sclerosis
|
Bayer Pharma AG
|
| Heberitro®
|
recombinant human erythropoietin
|
Anaemia
|
Siam Ltd, CIGB
|
| Heberon Alfa R®
|
recombinant human interferon-ᾳ 2b
|
Hepatitis B and C
HIV
Human Papillomavirus infections
Leukaemia
Metastatic renal carcinoma
Non-Hodgkin's lymphoma
Peyronie disease
|
CIGB, Changchun Heber
|
| Heberon®
|
recombinant human γ interferon
|
Hepatitis B and C
HIV
Human Papillomavirus infections
Leukaemia
Metastatic renal carcinoma
Non-Hodgkin's lymphoma
Peyronie disease
|
CIGB
|
| HeberPAG®
|
interferón-ᾳ 2b hu-rec
interferón γ hu-rec
|
Intradermal treatment
Intralesional
Intratumoral and perilesional basal cell carcinoma
|
CIGB
|
| Hebertrans®
|
leukocyte extract
|
Allergic or autoimmune diseases
Cancer
Cellular immunodeficiency
Herpes simplex
Herpes zoster
|
CIGB
|
| Hebervital®
|
filgrastim
|
Neutropenia
|
CIGB
|
| Insulatard®
|
human insulin (recombinant DNA), protamine sulfate
|
Diabetes
|
LIORAD, Novo Nordisk,
|
| Ior®Leukocim
|
granulocytic-colony stimulating factor
|
Neutropenia
|
CIM
|
| Norditropin®
|
somatotropin
|
Growth retardation
|
Novo Nordisk A/S Gentofte
|
| Peg-Heberon®
|
interferon-ᾳ 2b hu-rec conjugated with polyethylene glycol
|
Chronic hepatitis B and C
|
CIGB, Changchun Heber
|
| Rebif NF®
|
interferon β-1a
|
Multiple sclerosis
|
Merck Serono, Ares Trading
|
| Saizen®
|
somatotropin
|
Growth retardation
|
Merck Madrid, Merck Serono
|
Data updated on 8 October 2021.
Source: CECMED [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.
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| LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Requisitos de certificación de BPF en Chile, Cuba y Venezuela Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Requisitos de certificación de BPF en Chile, Cuba y Venezuela Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
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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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