FDA Clears Investigational New Drug Application for Proposed Biosimilar

Glenmark Pharmaceuticals initiates clinical investigation for GBR 310, its proposed biosimilar candidate for Xolair.

Glenmark Pharmaceuticals, a global pharmaceutical company, announced that the U.S. 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.

“This marks the second IND activation in 2017 for our growing respiratory portfolio,” said Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals. “In the seven years since the U.S. 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 respiratory or allergic disease.”

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.

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 U.S.1

(Source: PR Newswire)