Glenmark Pharmaceuticals bags USFDA approval
DSIJ Intelligence / 25 Apr 2017
Glenmark Pharmaceuticals has received the US Food and Drug Administration (USFDA) approval for the company’s Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310.
Glenmark Pharmaceuticals has received the US Food and Drug Administration (USFDA) approval for the company’s Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310. Its proposed biosimilar will assess its pharmacokinetics in comparison to XOLAIR (omalizumab) in healthy adult volunteers between 18 to 65 years of age.
Glenmark 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.
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. 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 stood at USD 1.7 billion (Rs 10935 crore) in the US.
The stock price of Glenmark Pharmaceutical increased 0.84 per cent in early trade, and is trading at Rs 889.25 on an intraday basis.