In a press release, Glenmark Pharmaceuticals announced today that the U.S. FDA has cleared Glenmark’s Investigational New Drug (IND) application of GBR 310, a proposed biosimilar of XOLAIR® (omalizumab), to initiate a first-in-human pharmacokinetics comparison study.

GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody. It is currently proposed for the treatment of allergic asthma and chronic idiopathic urticaria, which are the approved indications of XOLAIR®.  According to Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals, “GBR 310 has the potential to be among the first biosimilar candidates to be submitted for approval for a respiratory or allergic disease.”