Glenmark announces study supporting biosimilarity criteria for GBR 310 compared to the reference product Omalizumab
Glenmark is seeking use of GBR 310 for the same indications as the reference biologic for the treatment of allergic asthma and chronic idiopathic urticaria (CIU)
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced results from a Phase 1 study that suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between Glenmark’s GBR 310 proposed biosimilar and reference product omalizumab, marketed in the US under the brand name Xolair.
“We are pleased with the rapid progress made in the development of GBR 310, and look forward to meeting with the FDA this fall with the goal of advancing this proposed biosimilar candidate,” said Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals. “This progress is owed to the growth of talent at our global R&D centers, who continue to expand and take on new capabilities and challenges.”
GBR 310 is a recombinant DNA-derived humanised immunoglobulin G1 kappa monoclonal antibody. The proposed indications for GBR 310 are for the treatment of allergic asthma and chronic idiopathic urticaria (CIU). The now completed Phase 1 study enrolled 168 healthy adult volunteers, randomised 1:1 to receive either a single 150 mg dose of GBR 310 subcutaneously (SC) or a single 150 mg dose of U.S.-sourced omalizumab SC. The total duration of participation for each volunteer was approximately 127 days, including screening, in-house stay, outpatient and follow-up visits.
According to IQVIA sales data for the 12-month period ending May 2018, annual sales of Xolair were approximately $2.0 billion in the US.