1. Glenmark Pharma initiates clinical investigation for proposed biosimilar GBR 310

Glenmark Pharma initiates clinical investigation for proposed biosimilar GBR 310

Glenmark Pharmaceuticals has announced that the US Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310.

By: | Published: April 25, 2017 9:33 AM

 

Glenmark Pharmaceuticals has announced that the US Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310. (Photo: Reuters)

Pharma company Glenmark Pharmaceuticals on Tuesday informed the bourses that it has initiated an investigation for proposed biosimilar GBR 310, a proposed biosimilar candidate for Xolair. The company announced that the US Food and Drug Administration (FDA) 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 (omalizumab) in healthy adult volunteers between 18 – 65 years of age. GBR 310 has the potential to be among the first biosimilar candidates to be submitted for approval for a respiratory or allergic disease.

“This marks the second IND activation in 2017 for our growing respiratory portfolio. In the seven years since the US approval process for biosimilar medicines was signed into law, there have been few candidates successfully developed,” Kurt Stoeckli, president and chief scientific officer at Glenmark Pharmaceuticals said.

GBR 310 is a recombinant DNA-derived humanized 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.

On April 19, Glenmark Pharma had said that it has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg, the generic version of Pradaxa® Capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc.

Reacting to the news, shares of the pharma company were trading 0.72 per cent up at Rs 889.45 at 9.24 am. BSE Sensex was trading 169.22 points up at 29,825.06.

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