On September 26, Amneal Pharmaceuticals, Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ADL-018, a proposed biosimilar to Novartis AG’s XOLAIR (omalizumab). According to the press release, omalizumab is a humanized monoclonal antibody that targets free IgE and is indicated for the treatment of moderate to severe persistent asthma (6 years and older patients), chronic rhinosinusitis with nasal polyps (CRSwNP) (18 years and older patients), food allergies (>1 year and older patients), and chronic spontaneous urticaria (12 years and older patients). Kashiv BioSciences developed the product and Amneal holds exclusive U.S. commercialization rights, pending regulatory approval.
Subsequently, on October 6, Alvotech announced that the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for Kashiv BioSciences’s omalizumab biosimilar, which is also referred to as AVT23. Alvotech partnered with Kashiv BioSciences to develop the proposed biosimilar in the European Economic Area (European Union, Norway, Iceland and Lichtenstein), UK, Switzerland, Canada, Australia and New Zealand), and Advanz Pharma has licensed commercial rights for the biosimilar in those regions. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) accepted a Marketing Authorization Application for AVT23 earlier this year.