On March 30, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced that the U.S. Food and Drug Administration (“FDA”) has approved its denosumab biosimilar, PONLIMSI™ (denosumab-adet). PONLIMSI™ has been approved for all indications of the reference product, Amgen’s PROLIA®, including the treatment of osteoporosis in postmenopausal women at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, and other bone-related conditions. As we previously reported, the European Medicines Agency (“EMA”) granted marketing authorization for PONLIMSI™ in November 2025.
Additionally, Teva announced that its applications for a proposed biosimilar to XOLAIR® (omalizumab) have been accepted by both the FDA and the EMA. The applications include all indications approved for the reference product, Genentech and Novartis’s XOLAIR®, including the treatment of moderate-to-severe (U.S.)/severe (EU) persistent allergic asthma (ages 6+), chronic rhinosinusitis with nasal polyps (adults 18+), chronic spontaneous urticaria (ages 12+) and, in the U.S., IgE-mediated food allergies (ages 1+).
Stay tuned to Big Molecule Watch as we continue to monitor updates in the biosimilars industry.