Last update: 17 June 2022
The regulatory body for approval of medicines in Colombia is INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s National Institute of Food and Drug Monitoring. It is the national regulatory agency, a technical-scientific surveillance and control body, 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. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Colombia.
The agency evaluates all medicines for human and animal use, including biologicals (and productos bioterapéuticos similares – similar biotherapeutic products).
The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) is the body responsible for producing guidelines in the country. In January 2013, the Ministry released a new draft guideline for biologicals including similar biotherapeutic products in Colombia . This guideline was finalized in September 2014, when Decree 1782 was signed by Colombian President, Juan Manuel Santos Calderón. The decree will only come into effect once the Ministry has issued two important guidelines on immunogenicity and stability of biologicals.
The decree allows for three different regulatory pathways for biologicals; a complete file for new biologicals; a comparability pathway for drugs that are not new, but that are not yet sufficiently known, and an abbreviated pathway for well-known drugs and with fully characterized chemical substances .
In December 2014, INVIMA approved Remsima (infliximab) – the first producto bioterapéutico similar (similar biotherapeutic product) approved in Colombia .
However, there have been concerns raised about the Colombian decree by the European Union and the US. They have criticized the decree for the fact that it ‘could put health and safety at risk’, and lacks detail as to which biologicals the abbreviated pathway is intended for and how the pathway will be implemented .
Resolution 2950 was recently approved as a Guide for the Evaluation of the Comparability of Biological Medicines, with the aim of establishing the requirements and procedures to be taken into account by those who want to obtain the sanitary registration of biological medicines, since the marketing authorisation (sanitary registration) of these products depends in part on the information on the safety and efficacy of previously authorised pioneer products.
The Colombian Ministry of Health and Social Protection has the following guidelines regarding similar biotherapeutic products:
1. General guideline
This guideline covers all similar biotherapeutic products:
Decree 1782 Pharmacological and pharmaceutical assessments of biological medicines
Date: 18 September 2014
2. Other guidelines
The Colombian Ministry of Health and Social Protection issued other guidelines on similar biotherapeutic products:
Resolution 2950 issuing the Guideline for the Evaluation of the Comparability of Biological Medicinal Products and other provisions are issued
Date of entry into force: 6 November 2019
Resolution 553 amending Resolution 4490 of 2016 issuing the Immunogenicity Assessment Guideline for Biological Medicines
Date of entry into force: 1 March 2017
Resolution 4490 issuing the 'Guideline on Immunogenicity Assessment for Biological Medicinal Products' and other provisions
Date of entry into force: 27 September 2016
The context for the development of biosimilars in Latin America is very diverse due to the peculiarities related to economic, political, regulatory and cultural factors .
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.
Regulation of similar biotherapeutic products in Latin America
Colombia issues further draft guidelines for biologicals
EU guidelines for biosimilars
1. GaBI Online - Generics and Biosimilars Initiative. Colombia issues draft decree for registration of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Guidelines/Colombia-issues-draft-decree-for-registration-of-biologicals
2. Sierra Esteban FJ, García Cortes JA. 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
3. GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia
4. GaBI Online - Generics and Biosimilars Initiative. Concerns from EU and US over Colombian biologicals guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Guidelines/Concerns-from-EU-and-US-over-Colombian-biologicals-guidelines
5. 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
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