Amneal Pharmaceuticals (AMRX) announced the submission of a Biologics License Application, BLA, to the U.S. Food and Drug Administration, FDA, for a proposed biosimilar to XOLAIR, developed by Kashiv BioSciences. XOLAIR(R) is a registered trademark of Novartis AG. “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 about the opportunity to be part of the first wave of omalizumab biosimilars in this large and attractive market. Alongside our three marketed biosimilars, we expect another five biosimilar launches from 2026 to 2027, including our biosimilar to XOLAIR, positioning biosimilars as a key growth driver for Amneal.”
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