Why carry out this study?

YLB113 is being developed as a biosimilar of the reference product (RP) Enbrel® (etanercept).

Physicochemical characterization and preclinical studies have determined that YLB113 is biosimilar to the RP.

A phase 3 study was conducted in Europe, Japan, and India to compare the efficacy, safety, and immunogenicity of YLB113 with the RP over a treatment period of 52 weeks.

What was learned from the study?

This study demonstrated that YLB113 was biosimilar to the RP in terms of clinical safety, efficacy, and immunogenicity in patients with moderate-to-severe rheumatoid arthritis (RA).

Based on the same mechanism of action, the biosimilarity of YLB113 can be extrapolated to other therapeutic indications approved for the etanercept RP.

YLB113 provides another therapeutic option for patients with moderate-to-severe RA, which may improve patient access to etanercept.