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.”
Claim 50% Off TipRanks Premium and Invest with Confidence
- Unlock hedge-fund level data and powerful investing tools designed to help you make smarter, sharper decisions
- Stay ahead of the market with the latest news and analysis so your portfolio is always positioned for maximum potential
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on AMRX:
- Amneal Pharmaceuticals Positioned for Significant Growth with Strong Product Momentum and Strategic Advantages
- Amneal Pharmaceuticals receives FDA approval for bimatoprost ophthalmic solution
- Amneal Pharmaceuticals price target raised to $14 from $12 at JPMorgan
- Amneal Pharmaceuticals receives FDA approval of sodium oxybate oral solution
- Amneal gets FDA approval for risperidone extended-release injectable suspension