FDA Allows Omalizumab Biosimilar to Commence Clinical Trials

Glenmark Pharmaceuticals recently announced that the FDA cleared the investigational new drug application (IND) to start clinical trials of GBR 310, according to a press release.

The clinical trial will evaluate the pharmacokinetics of the proposed biosimilar to omalizumab (Xolair), the reference product. The researchers will include healthy volunteers aged 18 to 65 in the study.

GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody, which is being evaluated in the treatment of allergic asthma and chronic idiopathic urticaria, according to the release.

Glenmark Pharmaceuticals reported that the annual sales — ending in February 2017 – for omalizumab 150-mg injection was approximately $1.7 billion in the US, according to IMS sales data.

Asthma commonly affects children, with more than 18 million pediatric patients having the condition in the US. Allergic asthma is triggered by exposure to allergens that can be present year-round, including pet dander, which makes controlling exposure to allergens difficult.

Approximately 60% to 90% of children and 50% of adults with asthma experience an allergen-triggered asthma attack, according to the release.

Urticaria frequently presents as recurring hives or welts. The condition is common among people of all ages, but 1% of that population experiencing chronic hives or welts. Among patients with chronic urticaria, 70% report symptoms lasting more than 1 year and 14% report the condition enduring more than 5 years, according to the release.

Omalizumab has received approval to treat allergic asthma and chronic idiopathic urticaria. Since omalizumab’s launch, more than 200,000 patients 12 years and older with allergic asthma were treated.

The authorization to commence clinical trials may bring patients one step closer to treatment with a cost-effective biosimilar.

“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 7 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.”