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USFDA okays Glenmark’s first-in-human study for respiratory drug

LiveMint logoLiveMint 25-04-2017 PTI

New Delhi: Glenmark Pharmaceuticals on Tuesday 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 treatment of respiratory or allergic diseases.

“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.

“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 ending February 2017, annual sales of XOLAIR 150 mg injection was approximately $1.7 billion in the US.

Shares of the company were trading at Rs887.70, up 0.52%, on the BSE.

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