title: A non-innovator version of etanercept for treatment of arthritis.
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.
authors: BioPharmaceutical Division, Avesthagen Limited, ITPL, Bangalore, India.
authors: Sunit
authors: S
authors: Maity
authors: Rajesh
authors: R
authors: Ullanat
authors: Subhra
authors: S
authors: Lahiri
authors: Sunil
authors: S
authors: Shekar
authors: Geetha
authors: G
authors: Sodhan
authors: Ashutosh
authors: A
authors: Vyas
authors: Gopal
authors: G
authors: Dyaga
authors: Srinivas
authors: S
authors: Ireni
authors: Nirmala
authors: N
authors: Nair
authors: Yannis
authors: Y
authors: Sotsios
authors: Denis C
authors: DC
authors: Maria
authors: Villoo
authors: V
authors: Morawala-Patell
mesh_terms: D000818:Animals; D018501:Antirheumatic Agents / Q000494:pharmacology; D001168:Arthritis / Q000188:drug therapy*; D015153:Blotting, Western; D016466:CHO Cells; D045744:Cell Line, Tumor; D002851:Chromatography, High Pressure Liquid; D006224:Cricetinae; D003412:Cricetulus; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis / Q000235:genetics / Q000494:pharmacology*; D008297:Male; D051379:Mice; D008810:Mice, Inbred C57BL; D008808:Mice, Inbred CBA; D018124:Receptors, Tumor Necrosis Factor / Q000032:analysis / Q000235:genetics; D011994:Recombinant Proteins / Q000032:analysis / Q000494:pharmacology*; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D011994:Recombinant Proteins; D000068800:Etanercept