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

Maity S, Ullanat R, Lahiri S, Shekar S, Sodhan G, Vyas A, Dyaga G, Ireni S, Nair N, Sotsios Y, Maria DC, Morawala-Patell V., Biologicals, 2011 Nov;39(6):384-95. doi: 10.1016/j.biologicals.2011.08.014.

Abstract

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® and demonstrates similar efficacy in pre-clinical studies.

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