Tucked away in its first-quarter’s earnings report was the notice that Celltrion had filed its 351(k) application for approval of CT-P39 in March 2024. This could yield an FDA decision in the first or second quarter of 2025.
We reported last November that Celltrion was indeed leading the pack in the omalizumab biosimilar race. With US revenues over $2.5 billion and global sales of $3.8 billion, Xolair® sales have steadily grown for Roche.
However, that revenue may increase significantly, and very soon. The FDA approved a new indication for Xolair in February, for the treatment of multiple food allergies that are IgE-mediated.
The FDA approval allows omalizumab use in patients at least 1 year of age to reduce the risk of anaphylaxis through accidental exposure. The approval specifies that patients must continue to avoid foods that cause reactions, even with the use of omalizumab. It is not to be used as an emergency treatment of patients with anaphylaxis.
A phase 3 study published in the New England Journal of Medicine earlier this year found that 16-weeks of omalizumab therapy resulted in prevention of symptoms in patients with a history of peanut, milk, cashew, or egg allergies. According to the article, up to 8% of children and 10% of adults have significant food allergies. Omalizumab is an anti-IgE antibody that is injected subcutaneously.
The dose of Xolair® for patients with food allergies is within similar ranges as for its asthma and other indications. Although this use will be patent protected by the reference manufacturer (Roche), it is likely that payers will allow the use of any approved omalizumab biosimilars for this new food allergy indication.
Other potential omalizumab biosimilar candidates are currently being developed by Teva, Alvotech, and Aurobindo.
