Regulations for the registration of biological products were implemented in Colombia in 1995 through Ministerial Decree 677/1995. While a proposed draft decree providing for three routes for biological products: a complete route, a comparability route and an abbreviated route was published in January 2013 [1]. This guideline was finalized in September 2014, when Decree 1782 was signed by Colombian President, Juan Manuel Santos Calderón [2].

The proposed draft decree aims to facilitate the registration of productos bioterapéuticos similares (similar biotherapeutic products) in Colombia through an abbreviated pathway. However, the decree has been criticized by both the US and the European Union (EU) as 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].

The latest Colombian draft guidelines for biologicals cover stability and GMP of these products.

The GMP guideline complements the guidelines set out in the World Health Organization’s GMP document (Series of reports technical No. 823). It also defines the procedures for the control of biologicals, which are determined largely by the origin of the products and manufacturing methods.

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

The stability guideline establishes the parameters to be used and give guidance on performing stability studies, as well as outlining the conclusions required to establish shelf life and storage conditions.

The draft was released for public consultation and feedback could be submitted to the Ministry of Health and Social Protection via the emails: proymed@minsalud.gov.co and dmarquez@minsalud.gov.co. Comments on the draft were accepted by the Ministry of Health and Social Protection until 4 May 2015.

Stability guideline for biological drugs
Date: 11 May 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

The draft was released for public consultation and feedback could be submitted to the Ministry of Health and Social Protection via the emails: proymed@minsalud.gov.co and dmarquez@minsalud.gov.co. Comments on the draft were accepted by the Ministry of Health and Social Protection until 9 June 2015.

Editor’s comment
If you would like to receive an English version of the published stability guideline for biologicals please send us an email.

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
Colombian guidelines for productos bioterapéuticos similares

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 12]. Available from: www.gabionline.net/Guidelines/Colombia-issues-draft-decree-for-registration-of-biologicals 
2.   GaBI Online - Generics and Biosimilars Initiative. Colombian guidelines for productos bioterapéuticos similares [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Guidelines/Colombian-guidelines-for-productos-bioterapeuticos-similares
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 12]. Available from: www.gabionline.net/Guidelines/Concerns-from-EU-and-US-over-Colombian-biologicals-guidelines 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.