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

• Published in: Future oncology (London, England) Vol. 15; no. 36; pp. 4223 - 4234
• Main Authors: Jurczak, Wojciech, Cohen, Stanley, Illidge, Timothy M, Silva, Antonio da, Amersdorffer, Jutta
• Format: Journal Article
• Language: English
• Published: England Future Medicine Ltd 01.12.2019
• Subjects: Amino acids; analytical; Animals; Antibodies; Antigens; Apoptosis; Arthritis, Rheumatoid - drug therapy; Biological products; biosimilar medicines; Biosimilar Pharmaceuticals - administration & dosage; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - chemistry; Biosimilar Pharmaceuticals - therapeutic use; Blood cancer; clinical; Clinical Studies as Topic; Cloning; Cytotoxicity; Drug Development; Drug dosages; Drug Evaluation, Preclinical; FDA approval; Hematologic Neoplasms - drug therapy; Humans; Immunotherapy; Lymphoma; Manufacturing; Medicine; Molecular Targeted Therapy; Monoclonal antibodies; non-Hodgkin lymphoma; preclinical; Rheumatoid arthritis; rituximab; Rituximab - administration & dosage; Rituximab - adverse effects; Rituximab - chemistry; Rituximab - therapeutic use; SDZ-RTX; Targeted cancer therapy; totality of evidence; Treatment Outcome; clinical; analytical; preclinical; biosimilar medicines; SDZ-RTX; non-Hodgkin lymphoma; rheumatoid arthritis; rituximab; totality of evidence
• ISSN: 1479-6694; 1744-8301
• DOI: 10.2217/fon-2019-0430

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.