Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases
| Autor: | Timothy M Illidge, Wojciech Jurczak, Antonio da Silva, Stanley Cohen, Jutta Amersdorffer |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Oncology Cancer Research medicine.medical_specialty Follicular lymphoma Drug Evaluation Preclinical Arthritis Rheumatoid 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Drug Development immune system diseases hemic and lymphatic diseases Internal medicine medicine Animals Humans Molecular Targeted Therapy Biosimilar Pharmaceuticals Manchester Cancer Research Centre business.industry ResearchInstitutes_Networks_Beacons/mcrc Clinical Studies as Topic Biosimilar General Medicine medicine.disease 030104 developmental biology Treatment Outcome 030220 oncology & carcinogenesis Pharmacodynamics Rheumatoid arthritis Hematologic Neoplasms Rituximab business medicine.drug |
| Zdroj: | Jurczak, W, Cohen, S, Illidge, T M, Silva, A D & Amersdorffer, J 2019, ' Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases ', Future oncology (London, England), vol. 15, no. 36, pp. 4223-4234 . https://doi.org/10.2217/fon-2019-0430 |
| ISSN: | 1744-8301 |
| DOI: | 10.2217/fon-2019-0430 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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