Teva receives FDA approval for Prolia biosimilar
Teva Pharmaceutical announced FDA approval for Ponlimsi as a biosimilar to Prolia, while FDA and EMA also accepted applications for the company’s proposed Xolair biosimilar.
Teva Pharmaceutical has announced U.S. FDA approval for Ponlimsi as a biosimilar to Prolia, alongside regulatory progress for its proposed Xolair biosimilar in both the United States and Europe.
Key facts
- Teva received FDA approval for Ponlimsi (Denosumab-adet) as a biosimilar to Prolia.
- Ponlimsi was approved for all indications of the reference product.
- FDA and EMA accepted applications for Teva’s proposed Xolair (omalizumab) biosimilar.
- Teva and Alvotech also launched Selarsdi, a biosimilar to Stelara, in the U.S. in February 2025.
Teva Pharmaceutical has announced the U.S. Food and Drug Administration approval for Ponlimsi (Denosumab-adet, synonym: AMG-162) as a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair (Omalizumab, synonyms: rhuMab-E25; IGE25; RG-3648) by both the agency and the European Medicines Agency.
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. 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.
Ponlimsi expands Teva’s U.S. biosimilar portfolio
The approval of Ponlimsi gives Teva another important biosimilar product in the U.S. market and strengthens the company’s position in bone health and supportive care. Because Ponlimsi is approved for all indications of Prolia, Teva is entering a broad commercial category that includes osteoporosis treatment and bone mass preservation in patients undergoing certain cancer-related therapies.
The European Medicines Agency had already 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. That earlier European progress, together with the new FDA approval, gives the product regulatory momentum across two major pharmaceutical markets.
Teva also advances proposed Xolair biosimilar in the U.S. and Europe
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. Both agencies have now accepted those applications, marking another step forward for Teva’s broader biosimilar strategy.
Both submissions cover all approved indications for Xolair: chronic spontaneous urticaria in patients ages 12 and above, chronic rhinosinusitis with nasal polyps in adults ages 18 and above, moderate-to-severe persistent allergic asthma in patients ages six and above, and, in the United States, IgE-mediated food allergies in patients ages one and above. The filings are supported by analytical and clinical data on safety, immunogenicity, and efficacy comparable to Xolair.
Biosimilar momentum builds after Selarsdi launch
In February 2025, Teva and Alvotech announced the U.S. launch of Selarsdi (ustekinumab-aekn) injection, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). That launch, combined with the new Ponlimsi approval and the accepted Xolair biosimilar filings, suggests Teva is continuing to expand its biosimilar footprint across immunology, bone health, allergy, and inflammatory disease categories.
Taken together, the FDA approval of Ponlimsi and the dual regulatory acceptance for the proposed Xolair biosimilar represent another step in Teva’s effort to broaden patient access to biosimilar medicines in the United States and Europe. For Teva, the latest developments reinforce its push to build scale in the biosimilar market with products spanning multiple therapeutic areas and large reference brands.
