Open AccessA review of the totality of evidence in the development of ABP 798, a rituximab biosimilar
Author(s) -
Patrick Cobb,
Dietger Niederwieser,
Stanley Cohen,
Caroline Hamm,
Gerd R Burmester,
Neungseon Seo,
Sonya G. Lehto,
Vladimir Hanes
Publication year - 2022
Publication title -
immunotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.127
H-Index - 48
eISSN - 1750-7448
pISSN - 1750-743X
DOI - 10.2217/imt-2022-0024
Subject(s) - rituximab , biosimilar , medicine , rheumatoid arthritis , lymphoma , monoclonal antibody , pharmacodynamics , cd20 , oncology , immunology , pharmacokinetics , antibody
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.