Amneal Pharmaceuticals Inc. has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR® (omalizumab), developed in partnership with Kashiv BioSciences, LLC. This marks a significant step toward potential regulatory approval, positioning Amneal for first-wave entry into the $4 billion U.S. omalizumab market. The product is intended to treat conditions such as moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria. Amneal holds exclusive U.S. commercialization rights, pending FDA approval. No external grant or funding was reported in connection with this regulatory submission; the milestone reflects ongoing collaboration between Amneal and Kashiv BioSciences.