Teva Pharmaceutical Industries Ltd. (NYSE: 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).
“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 Chief Science Officer Steffen Nock. “With a strong early-stage pipeline and a suite of advancing programs, we see significant potential to address patient needs and fuel Teva’s long-term growth.”
The FDA approval of PONLIMSI was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety, and immunogenicity profile as the reference product, Prolia®. 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 at high risk for fracture, of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy.
TEVA shares edged up 11 cents to $28.85.
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