Teva Pharmaceutical Industries has announced a series of significant milestones in its biosimilars portfolio, underscoring progress in its broader “Pivot to Growth” strategy and strengthening its position in the competitive biologics market.
The company revealed that the U.S. Food and Drug Administration has approved PONLIMSI, a biosimilar to Prolia, for multiple indications. In addition, regulatory applications for a proposed biosimilar to Xolair have been accepted for review by both the FDA and the European Medicines Agency.
The FDA approval of PONLIMSI was supported by a comprehensive body of analytical and clinical evidence demonstrating comparable efficacy, safety, and immunogenicity to Prolia. The biosimilar is approved for all indications of the reference product, including the treatment of osteoporosis in postmenopausal women and men at high risk of fracture, glucocorticoid-induced osteoporosis, and bone loss associated with certain cancer therapies.
This approval marks a key achievement for Teva as it continues to expand access to more affordable biologic therapies. Biosimilars, which are designed to be highly similar to already approved biologic drugs, are increasingly viewed as critical tools in reducing healthcare costs while maintaining high standards of treatment.
In parallel, Teva’s proposed biosimilar to Xolair (omalizumab) is progressing through regulatory review in both the United States and Europe. The submissions include a Biologics License Application in the U.S. and a Marketing Authorization Application in the European Union. These filings cover all approved indications of the reference drug, including moderate-to-severe allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and certain food allergies.
The applications are backed by a robust dataset demonstrating similarity in efficacy, safety, and immunogenicity compared to Xolair. Acceptance of these filings represents an important step toward potential approval and commercialization in major global markets.
Teva also highlighted that its denosumab biosimilar received prior approval in Europe in late 2025, further reinforcing its growing international footprint in biosimilars.
Company leadership emphasized that these developments reflect the maturity of its biosimilars research and development engine, supported by a combination of in-house expertise and strategic partnerships. With a strong pipeline and multiple advancing programs, Teva aims to address unmet patient needs while driving long-term growth.
Overall, the latest announcements signal Teva’s continued momentum in the biosimilars space, positioning the company to compete more aggressively in a rapidly expanding segment of the pharmaceutical industry.