Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America

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dc.contributor.authorCastaneda-Hernandez, Gilberto
dc.contributor.authorEspinoza, Manuel Antonio
dc.contributor.authorPino, Luis Eduardo
dc.contributor.authorRico-Restrepo, Mariana
dc.contributor.authorSchiavetti, Bianca
dc.contributor.authorTeran, Enrique
dc.contributor.authorAzevedo, Valderilio Feijo
dc.date.accessioned2025-01-20T16:06:44Z
dc.date.available2025-01-20T16:06:44Z
dc.date.issued2024
dc.description.abstractBackgroundBiosimilars offer significant advantages for improving access to biologic treatments in Latin America. However, their uptake has been slow due to misconceptions, regulatory uncertainties, and inadequate pharmacovigilance.ObjectiveTo address these issues, Americas Health Foundation convened a multidisciplinary panel of regional experts in biosimilar use and interchangeability from Latin America. The panel assessed the current landscape and recommended steps to enhance access.ResultsKey recommendations include strengthening biosimilar regulations, ensuring transparent enforcement, implementing robust pharmacovigilance, and promoting collaboration among stakeholders to educate about the safety, efficacy, and economic advantages of biosimilars and their interchangeability.ConclusionsBy embracing biosimilars and interchangeability, Latin American countries can expand patient access, foster competition, diversify treatment sources, and enhance the sustainability of their healthcare systems. However, achieving these goals requires addressing knowledge gaps and biases among healthcare providers, patients, regulators, and government agencies. This can be accomplished through clear communication and the use of real-world evidence.
dc.description.abstractBiosimilars offer an opportunity to expand access to crucial biologic treatments in Latin America by providing lower-cost alternatives when patents expire. However, adopting biosimilars has been slow due to misconceptions and regulatory uncertainties. To address this, experts recommend considering approved biosimilars as interchangeable with reference products, allowing for switching without compromising safety or efficacy, with the limitation of switching only once per year. To improve access, well-defined regulations, enforcement, and transparency from regulatory agencies are necessary, along with education for healthcare providers, patients, and other stakeholders to address knowledge gaps and negative perceptions. Improved pharmacovigilance systems and collaboration between stakeholders can help communicate the benefits of biosimilars and interchangeability. By embracing biosimilars, Latin American countries can expand patient access, foster market competition, diversify treatment options, and improve the sustainability of healthcare systems.
dc.description.funderAbbott
dc.fuente.origenWOS
dc.identifier.doi10.1007/s12325-024-02990-y
dc.identifier.eissn1865-8652
dc.identifier.issn0741-238X
dc.identifier.urihttps://doi.org/10.1007/s12325-024-02990-y
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/89972
dc.identifier.wosidWOS:001329073800001
dc.issue.numero12
dc.language.isoen
dc.pagina.final4368
dc.pagina.inicio4357
dc.revistaAdvances in therapy
dc.rightsacceso restringido
dc.subjectBiosimilar pharmaceuticals
dc.subjectCost-benefit analysis
dc.subjectHealth inequities
dc.subjectLatin America
dc.subjectPatient advocacy
dc.subjectPharmacovigilance
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleRecommendations for Interchangeability in a Growing Biosimilar Market in Latin America
dc.typeartículo
dc.volumen41
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
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