Ítem
Solo Metadatos

Similar biotherapeutic products: overview and reflections.

Mostrar el registro sencillo de la publicación
dc.creatorDesanvicente-Celis, Zayrhospa
dc.creatorGomez-Lopez, Arleyspa
dc.creatorAnaya, Juan-Manuelspa
dc.date.accessioned2020-05-26T00:11:09Z
dc.date.available2020-05-26T00:11:09Z
dc.date.created2012spa
dc.description.abstractBiotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects involved. The objective of developing an SBP is to manufacture a molecule that is highly similar to a reference BP by conducting a comparability exercise (CE) that can demonstrate similar safety and efficacy. This CE consists of quality, as well as nonclinical and clinical evaluation. A case-by-case analysis approach guided by scientific and objective standards must be the foundation for the SBP approval process. The establishment of a balance between a comprehensive CE for SBPs and their reference BPs, and the design of costeffective strategies to provide better access to BPs, should be the key goal for national regulatory authorities.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.2217/imt.12.128
dc.identifier.issn1750743X
dc.identifier.issn17507448
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/24284
dc.language.isoengspa
dc.relation.citationEndPage1857
dc.relation.citationIssueNo. 12
dc.relation.citationStartPage1841
dc.relation.citationTitleImmunotherapy
dc.relation.citationVolumeVol. 4
dc.relation.ispartofImmunotherapy, ISSN:1750743X, 17507448, Vol.4, No.12 (2012); pp. 1841-1857spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-84878642716&doi=10.2217%2fimt.12.128&partnerID=40&md5=06225fc4748b831cefb49e1405a0ada6spa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.source.instnameinstname:Universidad del Rosariospa
dc.source.reponamereponame:Repositorio Institucional EdocURspa
dc.subject.keywordBiosimilar agentspa
dc.subject.keywordAnimalspa
dc.subject.keywordAutoimmune diseasespa
dc.subject.keywordBiological therapyspa
dc.subject.keywordBiotechnologyspa
dc.subject.keywordDrug approvalspa
dc.subject.keywordDrug designspa
dc.subject.keywordHumanspa
dc.subject.keywordMethodologyspa
dc.subject.keywordMolecularly targeted therapyspa
dc.subject.keywordNeoplasmspa
dc.subject.keywordReviewspa
dc.subject.keywordAnimalsspa
dc.subject.keywordAutoimmune diseasesspa
dc.subject.keywordBiological therapyspa
dc.subject.keywordBiosimilar pharmaceuticalsspa
dc.subject.keywordBiotechnologyspa
dc.subject.keywordDrug approvalspa
dc.subject.keywordDrug designspa
dc.subject.keywordHumansspa
dc.subject.keywordMolecular targeted therapyspa
dc.subject.keywordNeoplasmsspa
dc.titleSimilar biotherapeutic products: overview and reflections.spa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
Archivos
Colecciones
Artículos