A non-innovator version of etanercept for treatment of arthritis

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...

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Veröffentlicht in:Biologicals 2011-11, Vol.39 (6), p.384-395
Hauptverfasser: Maity, Sunit, Ullanat, Rajesh, Lahiri, Subhra, Shekar, Sunil, Sodhan, Geetha, Vyas, Ashutosh, Dyaga, Gopal, Ireni, Srinivas, Nair, Nirmala, Sotsios, Yannis, Maria, Denis C., Morawala-Patell, Villoo
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Sprache:eng
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Zusammenfassung: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.
ISSN:1045-1056
1095-8320
DOI:10.1016/j.biologicals.2011.08.014