BP001

BP001 is a biosimilar candidate of omalizumab (Xolair®), a humanized anti-immunoglobulin E (IgE) monoclonal antibody of the IgG1k class. Developed by BiosanaPharma (via its subsidiary Biosana Pty Ltd), BP001 is designed to treat moderate-to-severe persistent allergic asthma and chronic idiopathic (spontaneous) urticaria. It works by binding to free human IgE in the circulation and interstitial fluid, as well as membrane-bound IgE on B lymphocytes, thereby preventing IgE from attaching to high-affinity receptors (FcεRI) on mast cells and basophils and halting the allergic cascade. Notably, BP001 is the first clinical-stage monoclonal antibody produced using a fully continuous ('3C') biomanufacturing process, which is intended to significantly lower production costs. The candidate is also being developed in partnership with Alvotech under the code name AVT23 for Phase III clinical trials.