A review of the totality of evidence in the development of ABP 798, a rituximab biosimilar

Autor:	Patrick Cobb, Dietger Niederwieser, Stanley Cohen, Caroline Hamm, Gerd Burmester, Neungseon Seo, Sonya G Lehto, Vladimir Hanes
Rok vydání:	2022
Předmět:	Arthritis Rheumatoid Treatment Outcome Oncology Immunology Antibodies Monoclonal Humans Immunology and Allergy Rituximab Biosimilar Pharmaceuticals
Zdroj:	Immunotherapy. 14:727-740
ISSN:	1750-7448 1750-743X
Popis:	ABP 798 (RIABNI™) is a biosimilar to rituximab reference product (RP), a monoclonal antibody that targets CD20. Approval of ABP 798 was based on the totality of evidence generated using a stepwise approach which began by showing that it is structurally and functionally similar to rituximab RP. This analytical assessment was followed by a demonstration of pharmacokinetic/pharmacodynamic similarity in patients with rheumatoid arthritis. Comparative clinical efficacy and safety of ABP 798 with rituximab RP was demonstrated as a final step in patients with non-Hodgkin lymphoma and in those with rheumatoid arthritis. Overall, the totality of evidence supported the conclusion that ABP 798 is highly similar to rituximab RP and provided scientific justification for extrapolation to other approved indications of rituximab RP.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::35b8431751c776ffb9811e9b68fe42f2 https://doi.org/10.2217/imt-2022-0024 Zobrazit plný text záznamu