Concerns from EU and US over Colombian biologicals guidelines

In a letter to the Colombian President Juan Manuel Santos, the US Vice President Joe Biden said that it was believed by ‘World Health Organization and US experts’ that the biologic[al]s decree ‘could put health and safety at risk’.

The proposed Colombian draft decree provides for three routes for biological products: a complete route, a comparability route and an abbreviated route. It therefore aims to facilitate the registration of similar biotherapeutic products in Colombia through an abbreviated pathway.

The EU has also expressed its concern over the ‘general’ wording of article 7 of the proposed draft decree, which establishes the abbreviated pathway, as well as which biologicals the abbreviated pathway is intended for and how the pathway will be implemented.

In response to the EU concerns the Colombian Directorate of Medicines and Health Technology replied that ‘the pathways referred to in the Decree are information presentation pathways and not pathways for evaluating safety and efficacy.’ Furthermore, ‘a medicine may follow this route only if its active pharmaceutical ingredient has been sufficiently characterised using latest generation analytical methods and has a defined and extensively documented safety and efficacy profile’. Finally, ‘the health assessment proposed in the draft legislation applies to the whole product and not only the active ingredient’.

The proposed Colombian draft decree aims to enable the establishment of standards and regulatory procedures to ensure the quality, safety and efficacy of similar biotherapeutic products available in Colombia. However, although declaring that the required information must show the quality, efficacy and safety of the medicine there are no specifications as to how these properties should be demonstrated by the applicant.

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 EU. 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.

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Reference
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 2014 Sep 19]. Available from: www.gabionline.net/Guidelines/Colombia-issues-draft-decree-for-registration-of-biologicals