Universidad Peruana Cayetano Heredia

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

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dc.contributor.author Steinberg, Judith
dc.contributor.author Fragoso, Yara D.
dc.contributor.author Duran Quiroz, Juan Carlos
dc.contributor.author Garcia, Juan Raul
dc.contributor.author Guerra, Caroline
dc.contributor.author Rodriguez, Virginia
dc.contributor.author Carcamo Rodriguez, Claudia
dc.contributor.author Ciampi, Ethel
dc.contributor.author Correa-Diaz, Edgar
dc.contributor.author Macias, Miguel
dc.contributor.author Novarro, Nelson
dc.contributor.author Vizcarra-Escobar, Darwin
dc.contributor.author Oehninger Gatti, Carlos
dc.contributor.author Orozco, Geraldine
dc.contributor.author Carra, Adriana
dc.date.accessioned 2019-07-04T17:00:21Z
dc.date.available 2019-07-04T17:00:21Z
dc.date.issued 2019
dc.identifier.uri https://hdl.handle.net/20.500.12866/6884
dc.description.abstract The 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. Plain language summary available for this article. en_US
dc.language.iso eng
dc.publisher Springer
dc.relation.ispartofseries Neurology and Therapy
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject adverse drug reaction en_US
dc.subject alemtuzumab en_US
dc.subject Alemtuzumab en_US
dc.subject Biological drugs en_US
dc.subject Biosimilar en_US
dc.subject biosimilar agent en_US
dc.subject daclizumab en_US
dc.subject drug approval en_US
dc.subject drug efficacy en_US
dc.subject drug industry en_US
dc.subject drug marketing en_US
dc.subject drug quality en_US
dc.subject drug safety en_US
dc.subject drug use en_US
dc.subject education en_US
dc.subject European Medicines Agency en_US
dc.subject Glatiramoids en_US
dc.subject health care access en_US
dc.subject health care availability en_US
dc.subject health care cost en_US
dc.subject health care personnel en_US
dc.subject Interferon beta en_US
dc.subject multiple sclerosis en_US
dc.subject Multiple sclerosis en_US
dc.subject Natalizumab en_US
dc.subject Note en_US
dc.subject Ocrelizumab en_US
dc.subject pharmacovigilance en_US
dc.subject priority journal en_US
dc.subject risk management en_US
dc.subject South and Central America en_US
dc.subject therapeutic equivalence en_US
dc.title Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1007/s40120-019-0139-y
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.25
dc.relation.issn 2193-6536


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