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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)
Kashiv Biosciences has submitted its Biologics License Applications (BLA) for ADL-018 as a biosimilar to reference product XOLAIR® (omalizumab) to the U.S.
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[{"type":"text","content":"\n\nKashiv Biosciences has submitted its Biologics License Applications (BLA) for ADL-018 as a biosimilar to reference product XOLAIR® (omalizumab) to the U.S. Food and Drug Administration (FDA)\n\n\n\nThe Marketing Authorization Application (MAA) for ADL-018 as a biosimilar to XOLAIR® (omalizumab) has been accepted by the European Medicines Agency (EMA)\n\n\n\nLong-term growth opportunity given potential to be among the first-wave of biosimilar entrants in the ~$5.5+ billion global, ~$4.0+ billion U.S., and ~$1.0+ billion E.U. omalizumab market\n\n\n\n PISCATAWAY, N.J.--(BUSINESS WIRE)--\nKashiv BioSciences, LLC, a fully-integrated biopharmaceutical company, announced that they have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA), for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab).\n\n\nThe submissions are intended to seek approval in the United States and the European Economic Area, respectively. Omalizumab, a humanized monoclonal antibody that targets free IgE, 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), chronic spontaneous urticaria (12 years and older patients), and IgE-mediated food allergy (>1 year and older patients).\n\n\n“Kashiv continues to execute strongly on our expanding biosimilar portfolio, which already includes RELEUKO® (filgrastim-ayow) and FYLNETRA® (pegfilgrastim-pbbk). The BLA and EMA submission represents an important milestone in making our omalizumab biosimilar available to patients,” said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences. “Kashiv is proud to be one of the U.S.-based companies having manufacturing as well as marketing authorizations for multiple biosimilars, reflecting our commitment to cost-effective, high-quality medicines through strong partnerships.”\n\n\n“The earlier-than-expected BLA submission for this important therapeutic is excellent news for Amneal, as this product represents a significant potential growth catalyst in the coming years,” said Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines at Amneal Pharmaceuticals. “We are excited ab...