Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance

Autores
Matar, Pablo
Año de publicación
2022
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each undergo unique patterns of drift and evolution in their manufacturing processes (divergence), ultimately resulting in two products that would be no longer biosimilar. In cases where divergence in potency, safety and immunogenicity may be present, care should be taken with multiple switches between reference and biosimilar products: each time a switch occurs, the diff erence between products could be greater. Taking into account that post-marketing comparative biosimilarity validation is not required, drift, evolution and divergence may present greater challenges when assessing biosimilar. In a marketplace with multiple biosimilars of a given reference product and in the context of interchangeability with drift and divergence, pharmacovigilance systems should be strengthened.
Fil: Matar, Pablo. Universidad Nacional de Rosario. Facultad de Ciencias Médicas. Instituto de Genética Experimental. Sección de Oncología Experimental; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario; Argentina
Materia
DIVERGENCE
DRIFT
EVOLUTION
INTERCHANGEABILITY
PHARMACOVIGILANCE
VARIABILITY
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/201791
Acceder
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network_name_str CONICET Digital (CONICET)
spelling Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilanceMatar, PabloDIVERGENCEDRIFTEVOLUTIONINTERCHANGEABILITYPHARMACOVIGILANCEVARIABILITYhttps://purl.org/becyt/ford/3.4https://purl.org/becyt/ford/3Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each undergo unique patterns of drift and evolution in their manufacturing processes (divergence), ultimately resulting in two products that would be no longer biosimilar. In cases where divergence in potency, safety and immunogenicity may be present, care should be taken with multiple switches between reference and biosimilar products: each time a switch occurs, the diff erence between products could be greater. Taking into account that post-marketing comparative biosimilarity validation is not required, drift, evolution and divergence may present greater challenges when assessing biosimilar. In a marketplace with multiple biosimilars of a given reference product and in the context of interchangeability with drift and divergence, pharmacovigilance systems should be strengthened.Fil: Matar, Pablo. Universidad Nacional de Rosario. Facultad de Ciencias Médicas. Instituto de Genética Experimental. Sección de Oncología Experimental; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario; ArgentinaPro Pharma Communications International2022-08info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/201791Matar, Pablo; Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance; Pro Pharma Communications International; Generics and Biosimilars Initiative Journal; 11; 1; 8-2022; 36-402033-64032033-6772CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://gabi-journal.net/biosimilarity-is-not-a-transitive-property-implication-for-interchangeability-naming-and-pharmacovigilance.htmlinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:35:31Zoai:ri.conicet.gov.ar:11336/201791instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:35:31.685CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
title Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
spellingShingle Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
Matar, Pablo
DIVERGENCE
DRIFT
EVOLUTION
INTERCHANGEABILITY
PHARMACOVIGILANCE
VARIABILITY
title_short Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
title_full Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
title_fullStr Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
title_full_unstemmed Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
title_sort Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
dc.creator.none.fl_str_mv Matar, Pablo
author Matar, Pablo
author_facet Matar, Pablo
author_role author
dc.subject.none.fl_str_mv DIVERGENCE
DRIFT
EVOLUTION
INTERCHANGEABILITY
PHARMACOVIGILANCE
VARIABILITY
topic DIVERGENCE
DRIFT
EVOLUTION
INTERCHANGEABILITY
PHARMACOVIGILANCE
VARIABILITY
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.4
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each undergo unique patterns of drift and evolution in their manufacturing processes (divergence), ultimately resulting in two products that would be no longer biosimilar. In cases where divergence in potency, safety and immunogenicity may be present, care should be taken with multiple switches between reference and biosimilar products: each time a switch occurs, the diff erence between products could be greater. Taking into account that post-marketing comparative biosimilarity validation is not required, drift, evolution and divergence may present greater challenges when assessing biosimilar. In a marketplace with multiple biosimilars of a given reference product and in the context of interchangeability with drift and divergence, pharmacovigilance systems should be strengthened.
Fil: Matar, Pablo. Universidad Nacional de Rosario. Facultad de Ciencias Médicas. Instituto de Genética Experimental. Sección de Oncología Experimental; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario; Argentina
description Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each undergo unique patterns of drift and evolution in their manufacturing processes (divergence), ultimately resulting in two products that would be no longer biosimilar. In cases where divergence in potency, safety and immunogenicity may be present, care should be taken with multiple switches between reference and biosimilar products: each time a switch occurs, the diff erence between products could be greater. Taking into account that post-marketing comparative biosimilarity validation is not required, drift, evolution and divergence may present greater challenges when assessing biosimilar. In a marketplace with multiple biosimilars of a given reference product and in the context of interchangeability with drift and divergence, pharmacovigilance systems should be strengthened.
publishDate 2022
dc.date.none.fl_str_mv 2022-08
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/201791
Matar, Pablo; Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance; Pro Pharma Communications International; Generics and Biosimilars Initiative Journal; 11; 1; 8-2022; 36-40
2033-6403
2033-6772
CONICET Digital
CONICET
url http://hdl.handle.net/11336/201791
identifier_str_mv Matar, Pablo; Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance; Pro Pharma Communications International; Generics and Biosimilars Initiative Journal; 11; 1; 8-2022; 36-40
2033-6403
2033-6772
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/http://gabi-journal.net/biosimilarity-is-not-a-transitive-property-implication-for-interchangeability-naming-and-pharmacovigilance.html
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Pro Pharma Communications International
publisher.none.fl_str_mv Pro Pharma Communications International
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.070432

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