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Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases
Jurczak, W Cohen, S Illidge, Timothy M Silva, AD Amersdorffer, J
Jurczak, W
Cohen, S
Illidge, Timothy M
Silva, AD
Amersdorffer, J
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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.
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Date
2019
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Article
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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.