Glenmark Pharmaceuticals has said the US health regulator has cleared its investigational new drug (IND) application to initiate a first-in-human study for a proposed biosimilar for use in the treatment of respiratory or allergic disease.
“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 in healthy adult volunteers between 18 and 65 years of age,” Glenmark said in a BSE filing today.
“This marks the second IND activation in 2017 for our growing respiratory portfolio. GBR 310 has the potential to be among the first biosimilar candidates to be submitted for approval for a respiratory or allergic disease,” Glenmark Pharmaceuticals President and Chief Scientific Officer Kurt Stoeckli said.
Glenmark said GBR 310 is a recombinant DNA-derived humanised immunoglobulin G1 kappa monoclonal antibody.
“Its current proposed indication is for the treatment of allergic asthma and chronic idiopathic urticaria,” it added.
The reference product for GBR 310 is omalizumab, available under the brand name XOLAIR.
According to IMS sales data for the 12-month period ended February 2017, annual sales of XOLAIR 150 mg injection stood at approximately $1.7 billion in the US.
Glenmark Pharma shares were trading at Rs 887.70, up 0.52 per cent, on the BSE.