Biosimilars approved in Cuba

Biosimilars/General | Posted 08/10/2021 post-comment0 Post your comment

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 V21J07LT

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 Authorization date Manufacturer/Company name
Actrapid® mono-competent DNA of human insulin Diabetes Not available LIORAD, Novo Nordisk
Betaferon® recombinant interferon-β 1b Multiple sclerosis Not available Bayer Pharma AG
Heberitro® recombinant human erythropoietin Anaemia Not available 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
Not available 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
Not available CIGB
HeberPAG® interferón-ᾳ 2b hu-rec
interferón γ hu-rec
Intradermal treatment
Intralesional
Intratumoral and perilesional basal cell carcinoma
Not available CIGB
Heberprot-p® recombinant human epidermal growth factor Neuropathic and ischaemic ulcers Not available CIGB
Hebertrans® leukocyte extract Allergic or autoimmune diseases
Cancer
Cellular immunodeficiency
Herpes simplex
Herpes zoster
Not available CIGB
Hebervital® filgrastim Neutropenia Not available CIGB
Insulatard® human insulin (recombinant DNA), protamine sulfate Diabetes Not available LIORAD, Novo Nordisk, 
Ior®Leukocim granulocytic-colony stimulating factor Neutropenia Not available CIM
Norditropin® somatotropin Growth retardation Not available Novo Nordisk A/S Gentofte
Peg-Heberon® interferon-ᾳ 2b hu-rec conjugated with polyethylene glycol Chronic hepatitis B and C Not available CIGB,  Changchun Heber
Rebif NF®  interferon β-1a Multiple sclerosis Not available Merck Serono, Ares Trading
Saizen® somatotropin Growth retardation Not available 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.

Related articles
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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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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Source: CECMED

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