Teva today announced three milestones in its biosimilar portfolio. The United States Food and Drug Administration (FDA) has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia (denosumab) from U.S. pharmaceutical giant Amgen. Additionally, Teva’s applications for a proposed biosimilar candidate to Xolair (omalizumab), which is marketed by Genentech (a member of the Roche Group) and Novartis, have been accepted for review by both the U.S. FDA and the European Medicines Agency (EMA).
Ponlimsi is approved for all indications of the reference product Prolia, which include treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis, treatment of glucocorticoid-induced osteoporosis, as well as to increase bone mass in men receiving androgen deprivation therapy for prostate cancer and in women receiving adjuvant aromatase inhibitor therapy for breast cancer.
Previously, in November 2025, the EMA granted marketing authorization for this product in Europe.
The regulatory submissions for the biosimilar candidate to Xolair also include all indications approved for the reference product: persistent allergic asthma (ages 6+), chronic rhinosinusitis with nasal polyps (adults 18+), chronic spontaneous urticaria (ages 12+), and IgE‑mediated food allergies (ages 1+, for the U.S. only).
Prolia is Amgen’s best‑selling product: in 2025 it generated approximately $4.4 billion in revenue for the company. As for Xolair, according to Roche, its sales last year were about $3.8 billion, with Novartis accounting for roughly $1.7 billion of that amount.
Patent protection for Prolia expired in the U.S. in 2025, opening the market to lower‑cost biosimilars. As of early 2026, several biosimilars to Prolia have been registered and approved worldwide, manufactured by Sandoz, Celltrion, and Fresenius Kabi. In 2024–2025, the FDA and EMA approved a number of biosimilars, including Wyost, Xbryk, Osenvelt, and Conexxence.
In Russia, according to the State Register of Medicines, only two products with the INN denosumab are registered – Prolia® and Exdzhiva in different dosages, produced by the domestic company Petrovax Pharm.
