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Colombian guidelines for productos bioterapéuticos similares Posted 19/06/2015

Last update: 26 June 2015

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. 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 including 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 [1]. 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 routes for biologicals; a complete file for new biologicals; a comparability route for drugs that are not new, but that are not yet sufficiently known and a short route 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 [2].

The Colombian Ministry of Health and Social Protection has the following guidelines regarding similar biotherapeutic products:

1. Overarching Guideline
This guideline covers all similar biotherapeutic products:

Decree 1782 Pharmacological and pharmaceutical assessments of biological medicines
Date: 18 September 2014
www.minsalud.gov.co/Normatividad_Nuevo/Decreto%201782%20de%202014.pdf

2. Draft Other Guidelines
The Colombian Ministry of Health and Social Protection has the following draft guidelines under public consultation to develop guidelines relevant for similar biotherapeutic products:

GMP guideline for biological drugs
Date: 17 April 2015
End of consultation: 4 May 2015
www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/MET/BP-biologicos.pdf

Stability guideline for biological drugs
Date: 11 May 2015
End of consultation: 9 June 2015
www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/MET/Guia-estabilidad-medicamentos-biologicos.pdf#search=farmac%25C3%25A9utica%2520de%2520los%2520medicamentos%2520biol%25C3%25B3gicos

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 [3].

Editor’s comment
It should be noted that productos bioterapéuticos similares approved in Colombia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (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.

Related articles
Colombia issues further draft guidelines for biologicals

EU guidelines for biosimilars

References
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. 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
3. 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

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Source: MinSalud

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