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Glenmark starts clinical trial for biosimilar used to treat allergic asthma

The reference product for this biosimilar is omalizumab, sold under the brand name Xolair

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Glenmark office

Last Updated : Apr 25 2017 | 9:05 PM IST

The US Food and Drug Administration (FDA) has cleared Glenmark Pharmaceuticals’ 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.

“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. GBR 310 has the potential to be among the first biosimilar candidates to be submitted for approval for a

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