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dc.contributor.author
Matar, Pablo
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dc.date.available
2023-06-29T12:39:24Z
dc.date.issued
2022-08
dc.identifier.citation
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
dc.identifier.issn
2033-6403
dc.identifier.uri
http://hdl.handle.net/11336/201791
dc.description.abstract
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.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Pro Pharma Communications International
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
DIVERGENCE
dc.subject
DRIFT
dc.subject
EVOLUTION
dc.subject
INTERCHANGEABILITY
dc.subject
PHARMACOVIGILANCE
dc.subject
VARIABILITY
dc.subject.classification
Biotecnología relacionada con la Salud
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dc.subject.classification
Biotecnología de la Salud
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dc.subject.classification
CIENCIAS MÉDICAS Y DE LA SALUD
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dc.title
Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2023-06-28T16:53:48Z
dc.identifier.eissn
2033-6772
dc.journal.volume
11
dc.journal.number
1
dc.journal.pagination
36-40
dc.journal.pais
Bélgica
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dc.journal.ciudad
Mol
dc.description.fil
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
dc.journal.title
Generics and Biosimilars Initiative Journal
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/http://gabi-journal.net/biosimilarity-is-not-a-transitive-property-implication-for-interchangeability-naming-and-pharmacovigilance.html
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