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Amneal announces BLA submission of biosimilar candidate to XOLAIR
Summary by CDR – Chain Drug Review
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Amneal announces BLA submission of biosimilar candidate to XOLAIR
BRIDGEWATER, N.J. —Amneal Pharmaceuticals has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for a proposed biosimilar to XOLAIR (omalizumab), developed by Kashiv BioSciences, LLC. XOLAIR is a registered trademark of Novartis AG.Omalizumab, a humanized monoclonal antibody that targets free IgE, is indicated for the treatment of moderate to severe persistent asthma (6 years and older pat…
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