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Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab)

Potential first-wave entry into the $4+ billion U.S. market and an important new growth driver for AmnealBRIDGEWATER, N.J., Sept. 26, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC. XOLAIR® is a registered trademark of Novartis AG. Omalizumab, a humanized ...