Teva Pharmaceutical has announced the US Food and Drug Administration (FDA) approval for Ponlimsi (denosumab-adet) as a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair (omalizumab) by both the agency and the European Medicines Agency (EMA).
The FDA approval of Ponlimsi is based on a comprehensive evidence package, including analytical and clinical data showing immunogenicity, safety, and similar efficacy to Prolia.
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Ponlimsi is approved for all indications of the reference product, such as treating postmenopausal women with osteoporosis at high risk of fracture and increasing bone mass in men with osteoporosis.
Additional indications include glucocorticoid-induced osteoporosis in men and women at high fracture risk, increasing bone mass in men undergoing androgen deprivation therapy for nonmetastatic prostate cancer, and in women undergoing adjuvant aromatase inhibitor therapy for breast cancer.
The EMA granted marketing authorisation for Teva’s Ponlimsi in November 2025, following a positive opinion from the Committee for Medicinal Products for Human Use in the same year.
Regulatory submissions for Teva’s proposed Xolair biosimilar include a biologics licence application to the FDA and a marketing authorisation application to the EMA in the European Union (EU).
Both submissions cover all approved indications for Xolair: chronic spontaneous urticaria (ages 12 and above), chronic rhinosinusitis with nasal polyps (adults 18 and above), moderate-to-severe (US) / severe (EU) persistent allergic asthma (ages six and above), and, in the US, IgE-mediated food allergies (ages one and above).
They are supported by analytical and clinical data on safety, immunogenicity, and efficacy comparable to Xolair.
Teva biosimilars R&D head and chief science officer Steffen Nock said: “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.
“With a strong early-stage pipeline and a suite of advancing programmes, we see significant potential to address patient needs and fuel Teva’s long-term growth.”
In February 2025, Teva and Alvotech announced the US launch of the Selarsdi (ustekinumab-aekn) injection, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab).
