In Colombia, the regulatory body for the approval of biologicals is the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA).
INVIMA is the National Regulatory Agency, a technical-scientific surveillance and control entity, which works to protect the individual and collective health of Colombians, through the application of health standards associated with the consumption and use of food, medicines, medical devices and other products subject to health surveillance.
In 2014, Decree 1782 was issued, establishing the legal framework to regulate the production and marketing of biotechnological products, and including the basis to facilitate the advent of biosimilars in the market, on concrete definitions of comparability.
To date, INVIMA has approved four biosimilars [1] within the product classes of: 1) insulin; 2) tumour necrosis factor (TNF) inhibitor; 3) follicle stimulating hormone (FSH) for use in Colombia, see Table 1.
| Table 1: INVIMA approved biosimilars
|
| Product name
|
Active substance
|
Therapeutic area
|
Manufacturer/ Company name
|
| Basaglar
|
insulin glargine
|
Diabetes type 1 and 2
|
Lilly France
|
| Ojivri
|
trastuzumab
|
Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer
|
Mylan GmbH
|
| Prolugyn
|
human chorionic gonadotrophin hormone
|
Ovulation induction for infertility
|
LG Chem Ltd
|
| Remsima (CT-P13)
|
infliximab
|
Ankylosing spondylitis
Crohn's disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
|
Celltrion
|
Data updated on 11 February 2022.
Source: INVIMA.
|
Etanar, a biomimic of etanercept, is also authorized in Colombia for use in the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.
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 ‘medicamentos biosimilares’ approved in Colombia 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: Biosimilares aprobados en Colombia 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: Biosimilares aprobados en Colombia !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, 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 Feb 11]. Available from: www.gabionline.net/es/biosimilares/general/glosario-de-terminos-principales
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