Show simple item record

dc.contributor.authorJurczak, W
dc.contributor.authorCohen, S
dc.contributor.authorIllidge, Timothy M
dc.contributor.authorSilva, AD
dc.contributor.authorAmersdorffer, J
dc.date.accessioned2019-12-09T17:23:36Z
dc.date.available2019-12-09T17:23:36Z
dc.date.issued2019en
dc.identifier.citationJurczak W, Cohen S, Illidge TM, Silva AD, Amersdorffer J. Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases. Future Oncol. 2019;15(36):4223-34.en
dc.identifier.pmid31718287en
dc.identifier.doi10.2217/fon-2019-0430en
dc.identifier.urihttp://hdl.handle.net/10541/622620
dc.description.abstractSandoz rituximab (SDZ-RTX; Rixathon; GP2013), a rituximab biosimilar, was approved in June 2017 in Europe in all indications of reference rituximab. The stepwise SDZ-RTX development program generated extensive physicochemical, structural, functional, and biological data demonstrating a match with reference rituximab on all clinically relevant attributes. A focused clinical development program followed, in two indications selected for sensitivity to detect potential differences versus reference rituximab: rheumatoid arthritis (pivotal pharmacokinetics and efficacy evaluation) and follicular lymphoma (pivotal efficacy/safety evaluation). These trials demonstrated highly similar pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity profiles. The totality of evidence for biosimilarity for SDZ-RTX, combined with knowledge that B-cell depletion is common to each approved indication, allowed SDZ-RTX approval for use in all indications of reference rituximab.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.2217/fon-2019-0430en
dc.titleScientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseasesen
dc.typeArticleen
dc.contributor.departmentMaria Sklodowska-Curie Institute, Oncology Centre, Krakow, Polanden
dc.identifier.journalFuture Oncologyen
refterms.dateFOA2020-01-29T20:53:21Z


Files in this item

Thumbnail
Name:
fon-2019-0430.pdf
Size:
1.630Mb
Format:
PDF
Description:
Full text, Open Access article

This item appears in the following Collection(s)

Show simple item record