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 respiratory or allergic disease,” said Kurt Stoeckli, president and chief scientific officer at Glenmark Pharmaceuticals.
GBR 310 is a recombinant DNA-derived humanised 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 US.
Asthma is one of the most common diseases in children and affects more than 18 million 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 percent of children with asthma and in approximately 50 percent of adults.
Urticaria is a common skin disease that presents as spontaneously recurring hives or welts. It occurs across all age groups and about one percent of the population suffers from a chronic form of the disease. Among this group, 70 percent of people report symptoms that last for more than one year and 14 percent report symptoms that last for more than five years.
