New Delhi: Drug major Glenmark Pharma said that results from a phase 1 study suggest a similarity between the company’s proposed biosimilar GBR 310 and the reference product omalizumab, marketed in the USunder the brand name Xolair.
Glenmark’s proposed biosimilar GBR 310 is for use in the treatment of respiratory or allergic diseases.
Glenmark in a regulatory filing said, results from a phase 1 study suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between its proposed biosimilar GBR 310 and reference product omalizumab, marketed in the US under the brand name Xolair.
“We are pleased with the rapid progress made in the development of GBR 310, and look forward to meeting with the US Food and Drug Administration (USFDA) this fall with the goal of advancing this proposed biosimilar candidate,” said Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals.
The company said that the now completed phase 1 study enrolled 168 healthy adult volunteers, randomized to receive either a single 150 mg dose of GBR 310 subcutaneously (SC) or a single 150 mg dose of US-sourced omalizumab SC.
The total duration of participation for each volunteer was approximately 127 days, including screening, in-house stay, outpatient and follow-up visits.
Quoting IQVIA sales data for the 12-month period ending May 2018, Glenmark said the annual sales of Xolair were approximately USD 2 billion in the US.