Introduction: Biosimilars have the potential to improve access to medicines for
many across the globe. However, work is required to ensure adequate regulation,
pharmacovigilance and education about biosimilars. Colombia implemented biosimilars
regulation in 2017 and a 3rd Colombian Educational Workshop was organized by GaBI and
the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in 2019 to
follow up on progress and provide a forum for further discussion. Methods: The 3rd
Colombian Educational Workshop on Regulatory Assessment was held in Bogotá, Colombia on
30 April 2019. The format included expert speaker presentations, a panel discussion,
Q&A sessions and case study workgroup discussions. Participants included regulators,
clinicians, pharmacists, academics and healthcare professionals from Colombia who are
involved in biological/ biosimilar medicines evaluation, and expert speakers from
Canada, Europe and the US. Results: Presentations and topics of discussion included the
current status of biosimilars regulation in Colombia, how to carry out a quality
assessment of a biological/biosimilar, pharmacological and clinical studies, and
extrapolation of indications. Conclusion: The meeting helped to clarify many regulatory
concepts and concerns, and highlighted Colombia’s initial successes since the
implementation of its regulatory guidelines. In addition, the meeting acted as a forum
to exchange knowledge on best practice, and to discuss pharmacovigilance and the future
plans for education regarding biosimilars in Colombia. Several key action points were
concluded following the discussions.