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A non-innovator version of etanercept for treatment of arthritis
Sunit Maity1, Rajesh Ullanat, Subhra Lahiri
1BioPharmaceutical Division, Avesthagen Limited, ITPL, Bangalore, India.
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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