Teva Gets FDA Nod for Prolia Biosimilar, Xolair Candidate Accepted by EMA and FDA
Teva won FDA approval for Ponlimsi, a Prolia biosimilar, for all reference-product indications including postmenopausal and glucocorticoid-induced osteoporosis, expanding its US footprint. Regulatory submissions for an omalizumab biosimilar received FDA and EMA acceptance, covering chronic urticaria, nasal polyps, allergic asthma and food allergy.
1. FDA Approves Ponlimsi as Prolia Biosimilar
The FDA approval of Ponlimsi (denosumab-adet) grants Teva the right to market the biosimilar for all Prolia indications. The decision was based on comprehensive analytical, immunogenicity, safety and efficacy data demonstrating parity with the reference product across osteoporosis and related high-fracture-risk patient groups.
2. EMA Authorization and Xolair Biosimilar Applications
The EMA granted marketing authorisation for Ponlimsi in November 2025 after a positive CHMP opinion. Teva’s omalizumab biosimilar applications were accepted by both the FDA and EMA, covering all approved Xolair indications in chronic spontaneous urticaria, nasal polyps, persistent allergic asthma and IgE-mediated food allergies.
3. Teva’s Biosimilars Pipeline and Growth Outlook
Building on the February 2025 US launch of the Selarsdi ustekinumab biosimilar, Teva leverages deep internal R&D and strategic partnerships to expand its competitive biosimilars portfolio. Management highlights a strong early-stage pipeline and advancing programs aimed at driving long-term growth and addressing unmet patient needs.