Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis

被引：51
作者：
Zhao, Sizheng [1 ]
Chadwick, Laura [1 ]
Mysler, Eduardo [2 ]
Moots, Robert J. [1 ]
机构：
[1] Univ Liverpool, Univ Hosp Aintree, Inst Ageing & Chron Dis, Clin Sci Ctr,Dept Musculoskeletal Biol 1, Longmoor Lane, Liverpool L9 7AL, Merseyside, England
[2] Org Med Invest, Buenos Aires, DF, Argentina
来源：
CURRENT RHEUMATOLOGY REPORTS | 2018年 / 20卷 / 10期
关键词：
Adalimumab; Biosimilar; Rheumatoid arthritis; Amgevita; Cyltezo; Imraldi; ANTITUMOR NECROSIS FACTOR; HEAD-TO-HEAD; OPEN-LABEL EXTENSION; PHASE-III TRIAL; DOUBLE-BLIND; ABP; 501; MONOCLONAL-ANTIBODY; CONCOMITANT METHOTREXATE; COMBINATION THERAPY; PLUS METHOTREXATE;
D O I：
10.1007/s11926-018-0769-6
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
Adalimumab is one of the top-selling drugs worldwide. Its imminent patent expiration has seen the emergence of numerous biosimilar agents. In this article, we recap the evidence from bio-originator trials in rheumatoid arthritis (RA) to provide context for a critical review of biosimilar trial data. Currently, three adalimumab biosimilars are approved in Europe and/or the USA: Amgen's ABP 501 (AMJEVITA/Solymbic), Boehringer Ingelheim's BI 695501 (Cyltezo) and Samsung Bioepis's SB5 (Imraldi). All three agents met their pre-specified equivalence criteria. Subtle differences in adverse events and clinical responses between the reference and biosimilar products were noted. The introduction of adalimumab biosimilars will offer exciting opportunities in improving treatment access and increasing treatment options for RA and other licensed indications. Real-world data will further provide assurances on efficacy as well as safety.
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页数：10
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