Kashiv BioSciences, LLC announced that it has entered into an exclusive licensing agreement for ADL018, a proposed biosimilar to omalizumab referencing XOLAIR®, with Amneal Pharmaceuticals, Inc. (?Amneal?) for the United States. Omalizumab, which targets free IgE, is a humanized monoclonal antibody. 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, and 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. According to IQVIA®, U.S. annual sales for XOLAIR® for the 12 months ended April 2024 were approximately $3.2 billion. XOLAIR® is a registered trademark of Novartis AG.

The financial terms of the transaction were not disclosed, and any incremental expenses associated with these products are contemplated within Amneal?s guidance.