Colombian Regulation Includes 3 Pathways for Biosimilar Approval

As nations around the world seek to reap the rewards of biosimilar savings, some countries, including Colombia, are updating their regulatory processes to better facilitate the introduction of biosimilars. A paper, recently published in the Generics and Biosimilars Initiative Journal, outlines the new landscape for biosimilar products in Colombia.

Prior to having a dedicated approval process for biologics and biosimilars, all steps in the approval process for any product had to be carried out sequentially, not simultaneously: A pharmacological assessment was followed by submission of documentation for legal, quality, and process information; regulatory approval of quality controls; and laboratory testing.

However, in Colombia’s new regulatory framework, 4 assessment groups will work simultaneously to assess filings for safety and efficacy, quality and process, pharmacovigilance, and quality control. After these assessments take place, regulators will meet to make a final decision on the product. If they deliver a positive decision, the drug maker must next submit an application for marketing authorization and, after receiving approval, may launch its product.

In addition to making the approval process more efficient, new regulation has created 3 pathways for the submission of biologics:

• Submission of a complete dossier, which includes all of the elements needed to comply with the guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
• Demonstration of comparability, a stepwise approach based on clinical and nonclinical comparative studies for biosimilars versus their reference molecules
• Abbreviated comparability, an approach that requires only pharmacokinetic and pharmacodynamic data for a biosimilar of a reference product that has a sufficiently characterized reference product.

According to the authors, the pathway selected will depend upon the particular biologic drug or biosimilar molecule in question.

Reference

Esteban FJS, Cortes JAG. Regulations for biotheraputics approval in Colombia. GaBI J. 2018;7(1):26-28. doi: 10.5639/gabij.2018.0701.006.