Glenmark initiates clinical investigation of proposed biosimilar for Xolair
Glenmark Pharmaceuticals announced that the FDA has cleared its investigational new drug application to initiate a first-in-human trial of GBR 310, a proposed biosimilar, to measure its pharmacokinetics in comparison to Xolair in healthy adults aged 18 to 65 years.
GRB 310, a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody, has a proposed indication for treating allergic asthma and chronic idiopathic urticaria, according to a news release from Glenmark. Xolair (omalizumab, Genentech USA and Novartis Pharmaceuticals) is the reference product.
“This marks the second [investigational new drug] activation in 2017 for our growing respiratory portfolio,” Kurt Stoeckli, president and chief scientific officer at Glenmark, stated in the release, “In the seven years since the U.S. approval process for biosimilar medicines was signed into law, there have been few candidates successfully developed. GRB 310 has the potential to be among the first biosimilar candidates to be submitted for approval for a respiratory or allergic disease.”