FDA Approves Teva's PONLIMSI Biosimilar, Accepts Omalizumab Filing

Medicare patients without supplemental coverage currently absorb roughly $357 per injection in 20% cost-sharing for Prolia, Amgen's widely prescribed bone-loss treatment given twice yearly. The FDA's March 30 approval of Teva Pharmaceutical Industries' PONLIMSI (denosumab-adet) as a Prolia biosimilar creates the regulatory foundation for lowering that burden, but whether patients actually feel the difference depends on decisions Teva has yet to publicly address: whether it pursues an interchangeability designation, when it launches commercially in the United States, and what terms it secures from pharmacy benefit managers.

PONLIMSI received FDA clearance across all five indications of the reference product, covering postmenopausal women with osteoporosis at high fracture risk, men with osteoporosis, glucocorticoid-induced osteoporosis in both sexes, men on androgen deprivation therapy for nonmetastatic prostate cancer, and women receiving adjuvant aromatase inhibitor therapy for breast cancer. The agency based its decision on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety, and immunogenicity to Prolia. The European Medicines Agency had already granted marketing authorization for PONLIMSI in November 2025, following a positive opinion from its Committee for Medicinal Products for Human Use earlier that year.

"The FDA approval of PONLIMSI is a significant milestone that showcases our robust clinical, analytical, operational and regulatory expertise," said Yolanda Tibbe, Global Head of Biosimilars at Teva.

PONLIMSI enters a denosumab biosimilar market that has already grown crowded. Sandoz launched interchangeable biosimilars Jubbonti and Wyost in 2025, and Samsung Bioepis received approvals for two additional denosumab biosimilars in February 2025. UnitedHealthcare had already mandated biosimilar denosumab across its Medicare Advantage plans effective September 2025. Interchangeability designation is the regulatory status that allows pharmacists to substitute a biosimilar at the point of dispensing without additional prescriber authorization, the mechanism that makes generic-drug switches routine at retail pharmacies. Teva's press materials for PONLIMSI contain no mention of such a designation. Without one, PONLIMSI must win explicit PBM formulary placement before patients see meaningful price relief, a contracting process typically measured in months and timed to annual formulary cycles.

The accepted filing for Teva's omalizumab biosimilar candidate signals where the next wave of specialty-drug price pressure will land. Teva submitted a Biologics License Application to the FDA and a Marketing Authorization Application to the EMA, both covering all indications of Xolair, the Genentech and Novartis allergy drug prescribed for moderate-to-severe asthma, chronic rhinosinusitis, food allergy, and chronic spontaneous urticaria. Xolair's key U.S. formulation patent expired in November 2025, and the FDA had already approved Celltrion's omalizumab biosimilar Omlyclo with interchangeability status in March 2025. Teva's accepted filings place it as a second entrant in a high-cost specialty category where biologics can run thousands of dollars per year; if approved, a Teva omalizumab biosimilar would add another pressure point on prices that allergy and asthma patients have long shouldered.

"To receive U.S. FDA approval of PONLIMSI and the filing acceptances of our proposed biosimilar candidate to Xolair in the U.S. and Europe truly underscores the strength of our expanding global biosimilar portfolio and reaffirms our commitment to expand treatment options for patients," Tibbe said.

Steffen Nock, PhD, Teva's Head of Biosimilars R&D and Chief Science Officer, added that the company's "biosimilars R&D engine continues to demonstrate its depth and maturity." Teva frames both regulatory outcomes as milestones within its "Pivot to Growth" strategy, a push to build a broad biosimilars portfolio across immunology, oncology-related bone health, and other high-value therapeutic categories. Whether that strategy delivers actual savings to PONLIMSI patients will depend less on the FDA than on how quickly payers and PBMs decide it earns a preferred tier.