Glenmark Readying Xolair Biosimilar Challenge

 
• By Anju Ghangurde
  
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Glenmark has received US FDA clearance of an IND to start clinical studies with a proposed biosimilar version of Xolair. The Indian company appears confident of addressing any price-related challenges although the targeted launch is still some years away.

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...

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