Glenmark Pharmaceuticals update on phase 1 study for GBR 310

A proposed biosimilar and reference product omalizumab

Glenmark Pharmaceuticals 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 U.S. under the brand name Xolair.

GBR 310 is a recombinant DNA-derived humanized 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, randomized 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 U.S.

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