Proposed Xolair Biosimilar Gets FDA Approval for Clinical Trials

The FDA has granted Glenmark Pharmaceuticals’ investigational new drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar of Novartis’s reference drug omalizumab (Xolair). The clinical trial will assess the pharmacokinetics of GBR 310 in comparison with Xolair in healthy adult volunteers between 18 and 65 years of age.

“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, a recombinant DNA-derived humanized immunoglobulin G1 kappa (IgG1k) monoclonal antibody, binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to a membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. The patents on the reference drug omalizumab will expire in the US on June 20, 2017, and in Europe in August 2017.

Omalizumab is indicated for the treatment of moderate to severe persistent asthma that is not controlled by inhaled steroids, and for chronic idiopathic urticaria not controlled by antihistamines. A majority of asthma patients are able to control the disease with long-acting beta agonists (eg, Advair, Symbicort), inhaled steroids, and rescue inhalers, which are the mainstay of asthma maintenance therapy. But some 5% to 15% of patients have severe asthma, and struggle to control the disease. They usually turn to injected biologicals including omalizumab and GlaxoSmithKline’s mepolizumab (Nucala) to reduce airway inflammation.

If GBR 310 advances through the biosimilar approval process, it has a potentially strong market position. Treatment options for patients with severe asthma are forecast to improve quite significantly, per market research firm GBI Research, with biologics in particular gaining prominence over the small-molecule therapeutics. The worldwide sales of omalizumab touched $755 million in 2015, and currently, about one-third of drugs in the asthma pipeline are biologics, GBI states. Procedures such as bronchial thermoplasty to treat asthma are still regarded by health insurance payers as experimental, with most refusing coverage for the procedure even though the costs of a 1-time treatment can be less than some newer biologics, and its success rate is similar to other approved treatments.