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Biosimilars in rheumatology

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dc.contributor.authorAraújo, Filipe C.
dc.contributor.authorGoncalves, Joao
dc.contributor.authorFonseca, João Eurico
dc.date.accessioned2021-03-10T14:04:37Z
dc.date.available2021-03-10T14:04:37Z
dc.date.issued2019
dc.description© 2019 Elsevier Ltd. All rights reserved.pt_PT
dc.description.abstractBiotechnologicals are an invaluable resource in the treatment of patients with inflammatory rheumatic diseases (IRD) non-responsive or intolerant to conventional therapies. However, they are the main driver for increase in direct costs and represent a significant economic burden to healthcare systems worldwide. Since biosimilars are similar and more affordable versions of previously licenced biotechnologicals, they are expected to contribute to healthcare system sustainability and reduce inequities in treatment access. The landmark approval of CT-P13 as the first infliximab biosimilar paved the way for new infliximab but also etanercept, adalimumab and rituximab biosimilars. In Europe, North America and some countries of Asia, development is strictly regulated and only those presenting a totality-of-evidence dossier with highly similar physicochemical, biological and clinical performances are endorsed by regulatory agencies as biosimilars. The current article addresses the importance of biosimilar medicines in the treatment of IRD, as well as their innovative development and regulatory pathways, clinical evidence of similarity and challenges that may undermine their widespread use and success.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationPharmacol Res. 2019 Nov;149:104467pt_PT
dc.identifier.doi10.1016/j.phrs.2019.104467pt_PT
dc.identifier.eissn1096-1186
dc.identifier.issn1043-6618
dc.identifier.urihttp://hdl.handle.net/10451/46773
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.relation.publisherversionhttps://www.sciencedirect.com/journal/pharmacological-researchpt_PT
dc.subjectAdalimumabpt_PT
dc.subjectBiosimilarpt_PT
dc.subjectCT-P13pt_PT
dc.subjectEtanerceptpt_PT
dc.subjectExtrapolationpt_PT
dc.subjectInfliximabpt_PT
dc.subjectInterchangeabilitypt_PT
dc.subjectRheumatic diseasept_PT
dc.subjectRituximabpt_PT
dc.subjectSB4pt_PT
dc.subjectSwitchpt_PT
dc.titleBiosimilars in rheumatologypt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.startPage104467pt_PT
oaire.citation.titlePharmacological Researchpt_PT
oaire.citation.volume149pt_PT
person.familyNameAraújo
person.familyNameGoncalves
person.familyNameFonseca
person.givenNameFilipe C.
person.givenNameJoao
person.givenNameJoão
person.identifier.ciencia-idB11B-9815-C46F
person.identifier.ciencia-idF310-B85D-57C7
person.identifier.orcid0000-0003-2711-0683
person.identifier.orcid0000-0002-1245-3715
person.identifier.orcid0000-0003-1432-3671
person.identifier.ridB-2013-2008
person.identifier.scopus-author-id7103326175
person.identifier.scopus-author-id7101983519
rcaap.rightsrestrictedAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublicationcacab57e-ee8d-439a-96b5-1921331c5cfb
relation.isAuthorOfPublication59510be6-ca25-4f49-a4bb-8236d799fbe4
relation.isAuthorOfPublication1772dc12-7c55-4c76-ae2d-c23270172480
relation.isAuthorOfPublication.latestForDiscovery59510be6-ca25-4f49-a4bb-8236d799fbe4

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