A non-innovator version of etanercept for treatment of arthritis.

摘要

Etanercept is a soluble tumor necrosis factor (TNF) receptor originally approved for treatment of moderate-to-severe rheumatoid arthritis, juvenile rheumatoid arthritis, and psoriatic arthritis. We have developed a non-innovator version of the recombinant protein etanercept, with the investigational name AVG01 (trade name AVENT), using a novel expression vector-based technology. Here we show, by extensive analytical characterization, that AVG01 is highly similar to the reference product Enbrel(R) and demonstrates similar efficacy in pre-clinical studies.