Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases
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Maria Sklodowska-Curie Institute, Oncology Centre, Krakow, PolandIssue Date
2019
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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.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.Journal
Future OncologyDOI
10.2217/fon-2019-0430PubMed ID
31718287Additional Links
https://dx.doi.org/10.2217/fon-2019-0430Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.2217/fon-2019-0430