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

被引：1
|
作者：
Cobb, Patrick [1 ]
Niederwieser, Dietger [2 ]
Cohen, Stanley [3 ]
Hamm, Caroline [4 ]
Burmester, Gerd [5 ,6 ]
Seo, Neungseon [7 ]
Lehto, Sonya G. [7 ]
Hanes, Vladimir [7 ]
机构：
[1] St Vincent Frontier Canc Ctr, Billings, MT 59102 USA
[2] Univ Leipzig, Div Hematol & Oncol, Liebigstr 19, D-04106 Leipzig, Germany
[3] Metroplex Clin Res Ctr, Dallas, TX 75231 USA
[4] Western Univ Windsor, Windsor Oncol, Windsor, ON N8W 2X3, Canada
[5] Free Univ, Dept Rheumatol & Clin Immunol, Charite Pl 1, D-10117 Berlin, Germany
[6] Humboldt Univ, Charite Univ Med Berlin, Charite Pl 1, D-10117 Berlin, Germany
[7] Amgen Inc, One Amgen Ctr Dr, Thousand Oaks, CA 91320 USA
来源：
IMMUNOTHERAPY | 2022年 / 14卷 / 09期
关键词：
ABP; 798; biologics; biosimilars; non-Hodgkin lymphoma; rheumatoid arthritis; rituximab; ACTIVE RHEUMATOID-ARTHRITIS; FOLLICULAR LYMPHOMA; DOUBLE-BLIND; EFFICACY; SAFETY; TRIAL; METHOTREXATE; HEMATOLOGY; THERAPY;
D O I：
10.2217/imt-2022-0024
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
ABP 798 (RIABNI (TM)) 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.
引用
收藏
页码：727 / 740
页数：14
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