Glenmark Pharmaceuticals Initiates Clinical Investigation for GBR 310, its Proposed Biosimilar Candidate for XOLAIR
Glenmark Pharmaceuticals | April 25, 2017
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) 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.