Biosimilars for psoriasis: clinical studies to determine similarity

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorBLAUVELT, A.
dc.contributor.authorPUIG, L.
dc.contributor.authorCHIMENTI, S.
dc.contributor.authorVENDER, R.
dc.contributor.authorRAJAGOPALAN, M.
dc.contributor.authorROMITI, R.
dc.contributor.authorSKOV, L.
dc.contributor.authorZACHARIAE, C.
dc.contributor.authorYOUNG, H.
dc.contributor.authorPRENS, E.
dc.contributor.authorCOHEN, A.
dc.contributor.authorWALT, J. van der
dc.contributor.authorWU, J. J.
dc.date.accessioned2017-08-17T19:21:28Z
dc.date.available2017-08-17T19:21:28Z
dc.date.issued2017
dc.description.abstractBiosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design.
dc.description.indexMEDLINE
dc.description.sponsorshipAbbVie
dc.description.sponsorshipAmgen
dc.description.sponsorshipCentocor Ortho Biotech
dc.description.sponsorshipJanssen-Cilag
dc.description.sponsorshipWyeth
dc.identifier.citationBRITISH JOURNAL OF DERMATOLOGY, v.177, n.1, p.23-33, 2017
dc.identifier.doi10.1111/bjd.15067
dc.identifier.eissn1365-2133
dc.identifier.issn0007-0963
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/21509
dc.language.isoeng
dc.publisherWILEY
dc.relation.ispartofBritish Journal of Dermatology
dc.rightsrestrictedAccess
dc.rights.holderCopyright WILEY
dc.subject.otherplaque psoriasis
dc.subject.otherdouble-blind
dc.subject.otherphase-iii
dc.subject.otherextrapolation
dc.subject.othertrial
dc.subject.otherinfliximab
dc.subject.othertherapy
dc.subject.otherinterchangeability
dc.subject.otherrheumatology
dc.subject.otheradalimumab
dc.subject.wosDermatology
dc.titleBiosimilars for psoriasis: clinical studies to determine similarity
dc.typearticle
dc.type.categoryreview
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryIsrael
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryEspanha
hcfmusp.affiliation.countryItália
hcfmusp.affiliation.countryCanadá
hcfmusp.affiliation.countryÍndia
hcfmusp.affiliation.countryDinamarca
hcfmusp.affiliation.countryInglaterra
hcfmusp.affiliation.countryHolanda
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisoes
hcfmusp.affiliation.countryisoit
hcfmusp.affiliation.countryisoca
hcfmusp.affiliation.countryisoin
hcfmusp.affiliation.countryisodk
hcfmusp.affiliation.countryisogb
hcfmusp.affiliation.countryisonl
hcfmusp.affiliation.countryisoil
hcfmusp.author.externalBLAUVELT, A.:Oregon Med Res Ctr, Portland, OR 97223 USA
hcfmusp.author.externalPUIG, L.:Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Dept Dermatol, Barcelona, Spain
hcfmusp.author.externalCHIMENTI, S.:Univ Rome Tor Vergate, Rome, Italy
hcfmusp.author.externalVENDER, R.:Dermatrials Res Inc, Hamilton, ON, Canada; Venderm Innovat Psoriasis, Hamilton, ON, Canada
hcfmusp.author.externalRAJAGOPALAN, M.:Apollo Hosp, Chennai, Tamil Nadu, India
hcfmusp.author.externalSKOV, L.:Univ Copenhagen, Herllev & Gentofte Hosp, Copenhagen, Denmark
hcfmusp.author.externalZACHARIAE, C.:Univ Copenhagen, Herllev & Gentofte Hosp, Copenhagen, Denmark
hcfmusp.author.externalYOUNG, H.:Univ Manchester, Manchester Acad Hlth Sci Ctr, Salford Royal Hosp, Dept Dermatol, Manchester, Lancs, England
hcfmusp.author.externalPRENS, E.:Erasmus Univ, Med Ctr, Dept Dermatol, Rotterdam, Netherlands
hcfmusp.author.externalCOHEN, A.:Ben Gurion Univ Negev, Fac Hlth Sci, Siaal Res Ctr Family Med & Primary Care, Beer Sheva, Israel; Clalit Hlth Serv, Chief Phys Off, Dept Qual Measurements & Res, Tel Aviv, Israel
hcfmusp.author.externalWALT, J. van der:Int Psoriasis Council, St Louis, MO USA
hcfmusp.author.externalWU, J. J.:Kaiser Permanente Los Angeles Med Ctr, Dept Dermatol, Los Angeles, CA USA
hcfmusp.citation.scopus17
hcfmusp.contributor.author-fmusphcRICARDO ROMITI
hcfmusp.description.beginpage23
hcfmusp.description.endpage33
hcfmusp.description.issue1
hcfmusp.description.volume177
hcfmusp.origemWOS
hcfmusp.origem.pubmed27639072
hcfmusp.origem.scopus2-s2.0-85019723172
hcfmusp.origem.wosWOS:000406036200021
hcfmusp.publisher.cityHOBOKEN
hcfmusp.publisher.countryUSA
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