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Response regarding Colombian regulation of biotherapeutic products

dc.contributor.authorVaca, Claudia
dc.contributor.authorGaviria, Alejandro
dc.contributor.authorGómez, Carolina
dc.date.accessioned2019
dc.date.available2019
dc.date.issued2017
dc.identifier.citationVaca González C, Gómez C y Gaviría A. Respuesta sobre la regulación colombiana de los productos bioterapéuticos. Rev Panam Salud Publica. 2017;41:e135.es_ES
dc.identifier.issn1680 5348
dc.identifier.urihttps://iris.paho.org/handle/10665.2/51092
dc.description.abstract[EXCERPT]. Regarding a letter by Erika Lietzan (1) addressing our article on regulating biotechnology drugs in Colombia (2), we offer the following response. As Lietzan states, it is true that there is a global consensus on the two regulatory pathways to obtaining market authorization for biological medicines: the full dossier pathway for pioneer products and an abbreviated pathway for competitors (biosimilars), called the “comparability pathway” in Colombia. The scientific principles of the abbreviated pathway are clearly stated in our article, referencing the WHO Guidelines on Evaluation of Similar Biotherapeutic Products (3), which underscores the importance of demonstrating a high similarity of physicochemical and functional characteristics between the biocompetitor and the reference product...en_US
dc.language.isoenen_US
dc.relation.ispartofseriesRev Panam Salud Publica;41, sept. 2017es_ES
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 IGO*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/igo/*
dc.subjectColombiaen_US
dc.subjectUnited States Food and Drug Administrationen_US
dc.subjectPublic Healthen_US
dc.titleResponse regarding Colombian regulation of biotherapeutic productsen_US
dc.title.alternativeRespuesta sobre la regulación colombiana de los productos bioterapéuticoes_ES
dc.typeJournal articlesen_US
dc.rights.holderPan American Health Organizationen_US
paho.articletypeEditorialsen_US
paho.isfeatured0en_US
paho.source.centercodeUS1.1en_US
paho.subjectCat 4. Health Systemsen_US
dc.relation.ispartofjournalRevista Panamericana de Salud Públicaes_ES
dc.relation.ispartofjournalPan American Journal of Public Health


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