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Regulation of biologicals in Colombia Posted 20/04/2018

Since the introduction of Decree 1782 Colombia has been moving towards a new regulatory landscape for biologicals (productos bioterapéuticos) and similar biotherapeutic products (productos bioterapéuticos similares) in the country [1].

Decree 1782 was signed by Colombian President Juan Manuel Santos Calderón, in September 2014. The decree allows for three different routes for biologicals:

Complete dossier: for new biologicals
In place for over 20 years. Includes five modules for evaluation: 1. Administrative; 2. Summary; 3. Quality; 4. Non-clinical; and 5. Clinical.

Comparability approach: for drugs that are not new, but that are not yet sufficiently known
Comparability based on analytical characterization/studies. Uses a step-by-step process of clinical and non-clinical comparative studies designed for molecules with expired patents where molecules are compared against a reference product. Also includes five modules, however, in the comparability approach, modules 3−5 all include comparability exercises, whilst the clinical assessment required in module 5 is reduced.

Abbreviated comparability approach: short route for well-known drugs and drugs with fully characterized chemical substances
Based on the step-wise concept, the European Medicines Agency and the US Food and Drug Administration’s biosimilar guidelines recommend that clinical confirmatory studies are not always needed to demonstrate biosimilarity between reference and biosimilar products. Similarly, Colombia has developed this pathway for molecules where the reference product is sufficiently characterized, has well-defined and well-documented safety and efficacy profile, has strong clinical experience data and has strong pharmacovigilance evidence. The module system resembles that of the comparability approach but for module 5, only pharmacokinetics and pharmacodynamics data may be required.

The pathway to be followed will depend on the biological/similar biotherapeutic product in question.

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Related article
Colombian guidelines for productos bioterapéuticos similares

1. 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

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