Response regarding Colombian regulation of biotherapeutic products
| dc.contributor.author | Vaca, Claudia | |
| dc.contributor.author | Gaviria, Alejandro | |
| dc.contributor.author | Gómez, Carolina | |
| dc.date.accessioned | 2019-06-12T15:14:22Z | |
| dc.date.available | 2019-06-12T15:14:22Z | |
| dc.date.issued | 2017-09 | |
| dc.identifier.citation | Vaca 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.issn | 1680 5348 | |
| dc.identifier.uri | https://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.iso | en | en_US |
| dc.relation.ispartofseries | Rev Panam Salud Publica;41, sept. 2017 | es_ES |
| dc.rights | Attribution-NonCommercial-NoDerivs 3.0 IGO | * |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/igo/ | * |
| dc.subject | Colombia | en_US |
| dc.subject | United States Food and Drug Administration | en_US |
| dc.subject | Public Health | en_US |
| dc.title | Response regarding Colombian regulation of biotherapeutic products | en_US |
| dc.title.alternative | Respuesta sobre la regulación colombiana de los productos bioterapéutico | es_ES |
| dc.type | Journal articles | en_US |
| dc.rights.holder | Pan American Health Organization | en_US |
| paho.articletype | Editorials | en_US |
| paho.isfeatured | 0 | en_US |
| paho.source.centercode | US1.1 | en_US |
| paho.subject | Cat 4. Health Systems | en_US |
| dc.relation.ispartofjournal | Revista Panamericana de Salud Pública | es_ES |
| dc.relation.ispartofjournal | Pan American Journal of Public Health |
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