The use of biotechnology-derived medicines has\nsignificantly increased in recent decades. Although\nbiosimilars undergo rigorous characterization as well as clinical\nstudies to document their safety and effectiveness, they\nare highly complex molecules and small changes in the purification\nand production process of a biosimilar can have major\nimplications in its safety and effectiveness profile. In Latin\nAmerica, regulatory authorities have begun to establish welldescribed\nand standardized pathways that permit a biosimilar\nto gain commercial licensure. In order to be certain that a\nbiosimilar reaches its potential in ordinary clinical use, an intensive\npost-licensing monitoring system must be established\nsince it is the only means to ascertain the true similarity between\nthe original biologic and its biosimilar. Pharmacovigilance allows\nnational authorities to determine a drug�s performance in\nthe marketplace. An effective tracking and pharmacovigilance\nsystem for biological medicines has many steps and processes.\nTo aid policy makers in Latin American in addressing the many\nissues surrounding the establishment of an effective\npharmacovigilance system, the Americas Health Foundation\nconvened a group of experts to discuss the topic and develop\nrecommendations for implementation. The group discussed\ncurrent challenges and gaps in pharmacovigilance in Latin\nAmerica, paying close attention to the major issues associated\nwith traceability and pharmacovigilance of biosimilars following\ntheir approval. The recommendations developed should\nenable countries to accurately document the safety and performance\nof a biosimilar as experienced by patients under real-life\nconditions and have a significant impact on the successful implementation\nof pharmacovigilance of biosimilars throughout\nthe region.
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