Novartis Prepares to Defend Omalizumab Market as Potential Biosimilars Advance

December 10, 2018

In October, the FDA granted approval for a pre-filled syringe formulation of the reference product. Additionally, Novartis is looking to expand omalizumab’s indications, as it recently earned FDA’s breakthrough therapy designation in August 2018 as a treatment for food allergies.

Novartis recently announced that ligelizumab, a monoclonal antibody being investigated for the treatment of chronic spontaneous urticaria (CSU), will move on to phase 3 trials after demonstrating a clear dose-response relationship and improvements over another 1 of its older products, omalizumab (Xolair), in this cohort.

“Despite existing treatment options, too many people continue to struggle with the debilitating and potentially painful symptoms of CSU. Advancing ligelizumab to phase 3 is encouraging news for physicians and patients who have difficulty in controlling symptoms,” said Marcus Maurer, MD, professor of dermatology and allergy and director of research at the Department of Dermatology and Allergy of Charite-Universitätsmedizin in Berlin, Germany.

The trials come as welcome good news to Novartis, as the company looks to protect market share after omalizumab lost patent protection in the United States in June 2017, and in Europe in August 2017. Though omalizumab biosimilars have yet to be approved in either of the regulatory territories, at least 2 biosimilars are currently in development.

In July 2018, Glenmark Pharmaceuticals announced that its phase 1 study of GBR 310, a proposed omalizumab biosimilar, revealed similar pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles between its proposed omalizumab biosimilar and the reference Xolair.

Likewise, Sorrento Therapeutics, Inc, in collaboration with Mabtech, completed a combined phase 2 and phase 3 trial of STI-004 in China in 2016. Though the developers have not yet announced a filing of a Biologics License Application with the FDA, the potential biosimilar met its primary end point in the multicenter, randomized, double-blind, placebo-controlled trial.

Novartis, for its part, is fighting back against encroaching challengers in this therapeutic space. In October, the FDA granted approval for a pre-filled syringe formulation of the reference product. Additionally, Novartis is looking to expand omalizumab’s indications, as it recently earned FDA’s breakthrough therapy designation in August 2018 as a treatment for food allergies. In 2017, omalizumab brought in $1.75 billion in the United States alone.