Glenmark Pharmaceuticals has initiated Clinical Investigation for GBR 310, its proposed Biosimilar Candidate for XOLAIR. The US Food and Drug Administration (USFDA) cleared the company’s Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar, which will assess its pharmacokinetics in comparison to XOLAIR (omalizumab) in healthy adult volunteers between 18 – 65 years of age.
GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody. Its current proposed indication is for the treatment of allergic asthma and chronic idiopathic urticaria. The reference product for GBR 310 is omalizumab, available under the brand name XOLAIR.
According to IMS sales data for the 12-month period ending February 2017, annual sales of XOLAIR 150 mg injection was approximately $1.7 billion in the US.