Safety and Therapeutic Interchangeability of Infliximab with the Biosimilar CT-P13 in a Colombian Population
Keywords:
infliximab; biosimilar; drug prescribing; pharmacovigilance; biotechnology; prescribingAbstract
Introduction: In recent years, the number of biotechnological drugs registered worldwide has increased; among them, biosimilars account for the largest proportion. There is uncertainty regarding the interchangeability between originator drugs and biosimilars. Infliximab is a biopharmaceutical with multiple approved indications, and several biosimilars of this drug have been marketed over the past decade.
Objective: To characterize the phenomenon of switching (interchangeability) to the
biosimilar CT-P13 in infliximab prescriptions for Colombian patients.
Methods: A retrospective study was conducted using a database of drug prescriptions dispensed in Colombia, in which the reasons for switching were observed and reviewed, and correlated with adverse events reported by an active pharmacovigilance program.
Results: A total of 220 infliximab prescriptions with more than six months of treatment were identified, of which 149 were switched to the biosimilar CT-P13. The most common reasons for switching were administrative and related to dispensing availability. There were no differences in the frequencies of serious and mild adverse events between patients who were switched and those who continued with the original biologic drug. Treatment failure was the most frequent adverse event.
Conclusions: The switch to infliximab showed similarities to the results of other studies, although its cause is more closely related to the health insurance system; therefore, this practice does not appear to increase adverse events.
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