Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2034095 | Biologicals | 2011 | 12 Pages |
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.
Keywords
Related Topics
Life Sciences
Biochemistry, Genetics and Molecular Biology
Biochemistry, Genetics and Molecular Biology (General)
Authors
Sunit Maity, Rajesh Ullanat, Subhra Lahiri, Sunil Shekar, Geetha Sodhan, Ashutosh Vyas, Gopal Dyaga, Srinivas Ireni, Nirmala Nair, Yannis Sotsios, Denis C. Maria, Villoo Morawala-Patell,