Teva Gains Biosimilar Momentum in FDA Acceptance for Biosimilar Candidate to Xolair

 

• Teva’s biosimilar, PONLIMSI™, is now FDA-approved across all indications of the reference product, Prolia^® (denosumab), to treat a variety of debilitating bone conditions.
• Teva’s proposed biosimilar candidate to Xolair^® (omalizumab) is accepted for review by U.S. FDA and EU EMA.
• These milestones demonstrate Teva’s biosimilars expertise and are a significant step in Teva’s Pivot to Growth strategy, highlighting its transformation into a leading biopharmaceutical company with a broad biosimilars portfolio.

https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Gains-Biosimilar-Momentum-with-U-S--FDA-Approval-of-PONLIMSI-denosumab-adet-and-Dual-Filing-Acceptance-for-Biosimilar-Candidate-to-Xolair-omalizumab/default.aspx