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Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory

Wojciech Jurczak1, Stanley Cohen2, Timothy M Illidge3,4

  • 1Maria Skłodowska-Curie Institute, Oncology Centre, Kraków, Poland.

Future Oncology (London, England)
|November 14, 2019
PubMed

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.

Keywords:
SDZ-RTXanalyticalbiosimilar medicinesclinicalnon-Hodgkin lymphomapreclinicalrheumatoid arthritisrituximabtotality of evidence

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