Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases.
Future Oncol
; 15(36): 4223-4234, 2019 Dec.
Article
in En
| MEDLINE
| ID: mdl-31718287
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.
Key words
Full text:
1
Database:
MEDLINE
Main subject:
Arthritis, Rheumatoid
/
Hematologic Neoplasms
/
Biosimilar Pharmaceuticals
/
Rituximab
/
Drug Development
Type of study:
Prognostic_studies
Language:
En
Journal:
Future Oncol
Year:
2019
Type:
Article
Affiliation country:
Poland