Amneal Pharmaceuticals, Inc. announced the addition of omalizumab, referencing XOLAIR®?, to its biosimilar pipeline. Omalizumab is a humanized monoclonal antibody which targets free immunoglobulin E (IgE). It is an injectable prescription drug used to treat a number of chronic conditions such as severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), food allergies, and chronic spontaneous urticaria.

It is typically administered in a hospital or clinic setting. The biosimilar was developed by Kashiv BioSciences, LLC and is currently in a Phase III clinical trial, which began in the third quarter of 2023.