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

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). Read More