Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases
dc.contributor.author | Jurczak, W | |
dc.contributor.author | Cohen, S | |
dc.contributor.author | Illidge, Timothy M | |
dc.contributor.author | Silva, AD | |
dc.contributor.author | Amersdorffer, J | |
dc.date.accessioned | 2019-12-09T17:23:36Z | |
dc.date.available | 2019-12-09T17:23:36Z | |
dc.date.issued | 2019 | en |
dc.identifier.citation | Jurczak 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.pmid | 31718287 | en |
dc.identifier.doi | 10.2217/fon-2019-0430 | en |
dc.identifier.uri | http://hdl.handle.net/10541/622620 | |
dc.description.abstract | Sandoz 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.iso | en | en |
dc.relation.url | https://dx.doi.org/10.2217/fon-2019-0430 | en |
dc.title | Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases | en |
dc.type | Article | en |
dc.contributor.department | Maria Sklodowska-Curie Institute, Oncology Centre, Krakow, Poland | en |
dc.identifier.journal | Future Oncology | en |
refterms.dateFOA | 2020-01-29T20:53:21Z |