Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases
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 r...
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Published in | Future oncology (London, England) Vol. 15; no. 36; pp. 4223 - 4234 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
England
Future Medicine Ltd
01.12.2019
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Subjects | |
Online Access | Get full text |
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Summary: | 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. |
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ISSN: | 1479-6694 1744-8301 |
DOI: | 10.2217/fon-2019-0430 |