Health

Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab)

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 por

articleTeva Pharmaceutical Industries LimitedMarch 30, 202616/company/teva-pharmaceutical-industries-ltd/news/teva-gains-biosimilar-momentum-with-us-fda-approval-of-ponlimsitm-denosumab-adet-and-dual-filing-acceptance-for-biosimilar-candidate-to-xolairr-omalizumab
Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab)

About this update from Teva Pharmaceutical Industries Limited

[{"type":"image","alt":"Teva Pharmaceutical Industries Ltd","displaySize":"","headline":null,"caption":"Teva Pharmaceutical Industries Ltd","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":108,"url":"https://media.zenfs.com/en/globenewswire.com/bfbffad044ba3112cbe08e7be13bb2e7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/RVm0LbdD5btgTSMRlhCNHQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE1MQ--/https://media.zenfs.com/en/globenewswire.com/bfbffad044ba3112cbe08e7be13bb2e7","width":300,"height":108}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"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.","length":171,"tagName":"p"}]},{"val":[{"type":"text","content":"Teva’s proposed biosimilar candidate to Xolair® (omalizumab) is accepted for review by U.S. FDA and EU EMA.","length":107,"tagName":"p"}]},{"val":[{"type":"text","content":"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.","length":229,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":507,"olType":false},{"type":"text","content":"TEL AVIV, Israel and PARSIPPANY, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. The United States (U.S.) Food and Drug Administration (FDA) has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia®, and Teva’s applications for a proposed biosimilar candidate to Xolair® (omalizumab) have been accepted by both the U.S. FDA and the European Medicines Agency (EMA).","length":570,"tagName":"p"},{"type":"text","content":"“Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we’re building a highly competitive portfolio," said Steffen Nock, PhD, Head of Biosimilars R&D and Chief Science Officer at Teva. “With a strong early-stage pipeline and a suite of advancing programs, we see significant potential to address ...

More updates from Teva Pharmaceutical Industries Limited

androgen deprivation therapyosteoporotic fractureosteoporosisFood and Drug AdministrationChronic Kidney Diseasepostmenopausal womenchronic spontaneous urticariadenosumabTevaPONLIMSI