Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America

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dc.catalogadorgjm
dc.contributor.authorSteinberg, Judith
dc.contributor.authorDadalti Fragoso, Yara
dc.contributor.authorDuran Quiroz, Juan Carlos
dc.contributor.authorGarcía,Juan Raul
dc.contributor.authorGuerra, Caroline
dc.contributor.authorRodriguez, Virginia
dc.contributor.authorCárcamo Rodríguez, Claudia Andrea
dc.contributor.authorCiampi Diaz, Ethel Leslie
dc.contributor.authorCorrea-Diaz, Edgar
dc.contributor.authorMacías, Miguel
dc.contributor.authorNovarro, Nelson
dc.contributor.authorVizcarra, Darwin
dc.contributor.authorOehninger Gatti, Carlos
dc.contributor.authorOrozco, Geraldine
dc.contributor.authorCarrá, Adriana
dc.date.accessioned2024-01-19T14:48:18Z
dc.date.available2024-01-19T14:48:18Z
dc.date.issued2019
dc.description.abstractThe use of biosimilar drugs for multiple sclerosis (MS) has become widespread in Latin America, with the goal of reducing costs of treatments, promoting the sustainability of healthcare systems, and improving patient access to these therapies. There is currently a need to define and comply with requirements to guarantee the efficacy, safety, and quality of these drugs. Thus, the objective of the present study was to compile up-to-date information from each Latin American country assessed on (a) approval of biosimilar drugs by regulatory agencies; (b) use of biosimilar drugs, pharmacovigilance plans, risk management; and (c) update in the knowledge on different molecules. To do so, a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay, and Venezuela met to discuss the current situation regarding good practices and risks associated with the use of biosimilar drugs in their respective countries. Regulation, risk management plans, and pharmacovigilance in the whole continent must guide the strategies on the commercialization and access of biosimilar drugs and copies of complex molecules. Current regulations must be implemented for the registration of biosimilar drug products and complex molecules. It is paramount to ensure that new products follow the best quality standards at all stages beyond being safe and efficient. Uncontrolled interchangeability between original biological and biosimilar should be avoided. Latin America requires the implementation and full use of strong pharmacovigilance programs. National and multinational clinical studies are required to demonstrate the similarity in safety, efficacy, and immunogenicity profiles of complex molecules, as well as biological and biosimilar products.
dc.fechaingreso.objetodigital2024-04-15
dc.fuente.origenORCID
dc.identifier.doi10.1007/s40120-019-0139-y
dc.identifier.urihttps://doi.org/10.1007/s40120-019-0139-y
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/80696
dc.information.autorucEscuela de Medicina; Cárcamo Rodríguez, Claudia Andrea; 0000-0002-9430-216X; 562
dc.information.autorucEscuela de Medicina; Ciampi Diaz, Ethel Leslie; 0000-0002-7330-5433; 132794
dc.language.isoen
dc.nota.accesoContenido completo
dc.rightsacceso abierto
dc.subjectAlemtuzumab
dc.subjectBiosimilar
dc.subjectBiological drugs
dc.subjectGlatiramoids
dc.subjectInterferon beta
dc.subjectMultiple sclerosis
dc.subjectNatalizumab
dc.subjectOcrelizumab
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.titlePractical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America
dc.typeartículo
sipa.codpersvinculados562
sipa.codpersvinculados132794
sipa.trazabilidadORCID;2024-01-08
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