Glenmark announces encouraging results of Phase 1 study of biosimilar

Glenmark Pharmaceuticals has announced results from a Phase 1 study that suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between Glenmark’s GBR 310 proposed biosimilar and reference product omalizumab, marketed in the U.S. 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 FDA this fall with the goal of advancing this proposed biosimilar candidate,” said Mr. Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals. “This progress is owed to the growth of talent at our global R&D centers, who continue to expand and take on new capabilities and challenges.”

GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody. The proposed indications for GBR 310 are for the treatment of allergic asthma and chronic idiopathic urticaria (CIU). The now completed Phase 1 study enrolled 168 healthy adult volunteers, randomized 1:1 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.

According to IQVIA sales data for the 12-month period ending May 2018, annual sales of Xolair were approximately $2.0-bn in the US.

Common condition

Asthma is one of the most common diseases in children and affects more than 18-mn people older than 18 in the US. Allergic asthma is unique because it is triggered by exposure to year-round allergens like pet dander and dust mites. Allergies trigger asthma attacks in 60-90% of children and in approximately 50% of adults with asthma.

Urticaria is a common skin disease that presents as spontaneously recurring hives or welts. It occurs across all age groups and about 1% of the population suffers from a chronic form of the disease. Among this group, 70% of people report symptoms that last for more than one year and 14% report symptoms that last for more than five years.