This article analyses the realities of Colombia as part as a broader study carried out by Iglesias Galiano M, focused on some reference countries as well as those countries of the region with level IV according to Pan American Health Organization (PAHO) classification, which have implemented guidelines for the authorization of biotechnological and biosimilar medicines in relation to the management of the nomenclature.
In the Colombian legal system, the Ministry of Health and Social Protection (Ministerio de Salud y Protección Social, MSPS) established a regulatory framework for ‘the health registration of new (pioneer) and known (biocompetitor, biosimilars or biogenerics) biological drugs’, through Decree 1782 of 2014.
The decree establishes three pathways for the approval of biological drugs/biotherapeutics in Colombia the full dossier approach, the comparability approach and the abbreviated comparability approach for evaluation in terms of safety and efficacy, quality and process, pharmacovigilance and quality control. Regardless of the pathway selected, a common basic information contained in article 6 of the aforementioned decree must be submitted . This information, which will be essential to provide, are the following: 1. detailed description of the process and place of production; 2. expression system; 3. biological identity tests; 4. potency evaluation; 5. physicochemical properties; 6. biological activity evaluation; 7. purity evaluation; 8. immunogenicity tests, and 9. risk management plan [1, 2].
The Colombia National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA) in Article 19 of the same decree (1782-2014) establishes the acronyms to be considered for health registrations granted to biologicals and does not refer to the nomenclature or common name of the product. The decree indicates that the letters MB (Medicamento Biológico) followed by the health registration number will be assigned to biological drugs while MBT (Medicamento Biotecnológico) will be assigned to biotechnological drugs. INVIMA will establish the transition regime for the inclusion of the initials MB and MBT in the nomenclature of such registration .
A summary of the nomenclature criteria established by INVIMA for biological and biosimilar medicines is presented below in Table 1.
| Table 1: Health regulation of the nomenclature of biologicals and biosimilars by INVIMA in Colombia
| Health regulation
|| Nomenclature criteria
| Decree 1782-2014
– Does not issue guidance
– Maintains the same INN of the innovator biological medicine in authorized biological medicines
– Does not use the term 'biosimilar'
Data updated on 8 April 2022.
INVIMA: Instituto Nacional de Vigilancia de Medicamentos y Alimentos; INN: International Nonproprietary Name.
On the experiences in Colombia in the analysis of biosimilar drugs with respect to informed consumption, it refers that by maintaining the same international non-proprietary name in all authorization routes (full, comparability and abbreviated), the lack of information and identification available with respect to reference and biosimilar biological drugs in public databases and authorization through judicial channels create a barrier to informed consumption that guarantees the quality and safety of drugs circulating in Colombia .
The first biosimilar approved in Colombia was Remsima (infliximab) in December 2013 .
Until 2020, nine biosimilars have been registered by INVIMA , one of which was authorized by the US Food and Drug Administration (FDA) and four approved by the European Medicines Agency (EMA). The remaining five biosimilars were not authorized by either of these two administrations. In addition, seven licensing applications were submitted in 2020 which have an average of 28 months of study for approval.
This article is the fourth in a series of articles, after Brazil, Argentina and Mexico, on the nomenclature of biological and biosimilar medicines in several Latin American countries.
Nomenclature of biologicals and biocomparables in Mexico
Nomenclature of biologicals and biosimilars in Argentina
Nomenclature of biologicals and biosimilars in Brazil
Guide for the comparability assessment of biological drugs in Colombia
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1. García Cortes JA, Sierra Esteban FJ. Regulations for biotherapeutics approval in Colombia. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):26-8. doi:10.5639/gabij.2018.0701.006
2. Ministerio de Salud y Protección Social. Decreto Número 1782 de 2014 [homepage on the Internet]. [cited 2022 Apr 8]. Available from: https://www.minsalud.gov.co/Normatividad_Nuevo/Decreto%201782%20de%202014.pdf
3. Iglesias Galiano M. Situación de la nomenclatura de biológicos y biosimilares en países de referencia, países de la región y del Perú propuestas de implementación. DSpace Repository. 2021.
4. Bernal-Camargo DR, Gaitán-Bohórquez JC, León Robayo ÉI. Medicamentos biosimilares en Colombia: una revisión desde el consumo informado. Rev Cienc Salud. 2018;16(2):311-39.
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 8]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-colombia
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