Global pharmaceutical major Glenmark Pharmaceuticals has received the US Food and Drug Administration (USFDA) approval for the companys Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar candidate for Xolair which is used to treat persistent asthma in patients 6 years of age or older.
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 a company satatement.
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, Stoeckli said.
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. Urticaria is a common skin disease that presents as spontaneously recurring hives or welts. It occurs across all age groups and about one per cent of the population suffers from a chronic form of the disease.