The US FDA has approved Glenmark Pharmaceuticals Ltd.’s Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310, the firm’s proposed biosimilar version of Roche/Novartis AG's Xolair (omalizumab); the study will assess the biosimilar’s pharmacokinetics in comparison to Xolair in healthy adult volunteers between 18 and 65 years of age.
GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody and its current proposed indication is for the...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Scrip for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?