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.
|Number of pages||8|
|Journal||Expert Opinion on Biological Therapy|
|Publication status||Published - 2021|
Bibliographical noteFunding Information:
All authors have received non-financial support from LG Chem, Ltd. (formerly, LG Life Sciences, Ltd.) and YW Song has received a grant from the Ministry of Science, ICT and Future Planning (NRF-2015M3A9B6052011, 2019M3A9A8065574) related to the submitted work. All authors have received grants for the published double-blind Phase III study  and the subsequent extension study of LBEC0101  from LG Chem, Ltd., outside the submitted work. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
© 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
All Science Journal Classification (ASJC) codes
- Drug Discovery
- Clinical Biochemistry