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Kashiv Biosciences Announces Submission of Biologics License Application to U.S. FDA and Acceptance of Market Authorization Application by European Medicines Agency for ADL-018, a Proposed Biosimilar to XOLAIR® (omalizumab)

ALVOAMRX
  • Kashiv BioSciences submitted a Biologics License Application (BLA) for ADL-018, a biosimilar to XOLAIR® (omalizumab), to the U.S. FDA & the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA).
  • The submissions aim to secure approval in the United States & the European Economic Area for the proposed biosimilar.
  • ADL-018 targets the global omalizumab market valued at ~$5.5 billion, with specific segments of ~$4.1 billion in the U.S. & ~$1.0 billion in the E.U. based on 12-month sales ending June 2025.
  • Omalizumab is indicated for moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, & IgE-mediated food allergy across various age groups.
  • ADL-018 matches the pharmaceutical presentations, dosage strength, route of administration, & dosing regimen of the U.S. & E.U.-approved omalizumab reference product.
  • Alvotech partnered with Kashiv BioSciences to develop the biosimilar, referred to as AVT23 by Alvotech & ADL-018 by Kashiv, for markets including the EEA, UK, Switzerland, Australia, New Zealand, & Canada.
  • Amneal Pharmaceuticals views the earlier-than-expected BLA submission as a significant growth catalyst & plans to launch this biosimilar alongside others between 2026 & 2027.
  • Kashiv BioSciences is a fully-integrated biopharmaceutical company noted for having both manufacturing & marketing authorizations for multiple biosimilars.
  • XOLAIR® is a registered trademark of Novartis AG.