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LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis

Authors
 Yeong Wook Song  ;  Yong-Beom Park  ;  Jinseok Kim 
Citation
 EXPERT OPINION ON BIOLOGICAL THERAPY, Vol.21(1) : 1-8, 2021-01 
Journal Title
 EXPERT OPINION ON BIOLOGICAL THERAPY 
ISSN
 1471-2598 
Issue Date
2021-01
Keywords
Biosimilar ; TNF inhibitor ; equivalence ; etanercept ; pharmacokinetics ; rheumatoid arthritis
Abstract
Introduction: Treatment of rheumatoid arthritis (RA) has been revolutionized by the introduction of biologic disease-modifying antirheumatic drugs, such as tumor necrosis factor (TNF) inhibitors. With patent expiry approaching for many expensive biologic molecules, such as etanercept, more affordable biosimilar drugs are being developed. LBEC0101 is an etanercept biosimilar approved in Japan and South Korea for all etanercept indications including RA.Areas covered: We discuss the pharmacological characteristics, pharmacokinetics, efficacy, and safety of LBEC0101 compared with the etanercept reference product (ETN-RP). Preclinical studies showed that the binding affinity to TNFα and biological activity of LBEC0101 were similar to those of the ETN-RP. The pharmacokinetic profile of LBEC0101 was also similar to that of the ETN-RP. A Phase III, randomized, double-blind, 54-week study showed that the efficacy of LBEC0101 was equivalent to that of the ETN-RP in RA patients. An extension study showed that efficacy was sustained long-term in patients receiving LBEC0101 and in those switching from the ETN-RP to LBEC0101. The safety profile of LBEC0101 was also confirmed to be comparable with the ETN-RP.Expert opinion: LBEC0101 has shown equivalent pharmacokinetics and efficacy and comparable safety to the ETN-RP, and the lower cost of LBEC0101 provides a good cost-benefit ratio.
Full Text
https://www.karger.com/Article/Abstract/503847#
DOI
10.1080/14712598.2020.1701650
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Yong Beom(박용범)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/175657
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