|Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) have emerged as a new class of biotherapeutic agent and they are becoming increasingly available worldwide. Columbia has developed regulations for biosimilar approval and introduction and is beginning to implement these to allow access to biosimilars.
Methods: There was an Educational Workshop and a Meeting that took place in Bogotá, Columbia on 14 June 2016 and 15 August 2017 respectively. These were organised by GaBi in association with INVIMA. At the first meeting, presentations and discussions took place that outlined issues related to physicochemical characterization, functional assays, cell expression systems, analytical/comparability studies, QC standards, and clinical assessment of biologicals/similar biotherapeutic products. These were followed by case study working sessions. At the second meeting, presentations covered the topics of specifications, comparability in production process, analytical comparability/methods, reference standards and materials, degradation studies, and development/validation of host cell protein assays of biotechnology products/biosimilars.
Results: Discussions identified knowledge gaps and differences of opinion and practice concerning the regulatory evaluation of potential SBPs in Columbia
Conclusion: Columbia has developed a regulatory framework that it is ready to put in place and feedback from European and American experts helped to highlight areas of weakness.
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