TEL AVIV, Israel & PARSIPPANY, N.J., USA, March 30, 2026
Teva Pharmaceutical Industries has received U.S. FDA approval for PONLIMSI™ (denosumab-adet), a biosimilar to Prolia®, while also securing regulatory filing acceptances for its biosimilar candidate to Xolair® (omalizumab), marking a major milestone in its biosimilars expansion and global growth strategy. These developments highlight Teva’s strengthening position as a leading biopharmaceutical company with a diversified biosimilars portfolio, addressing critical needs in bone health and immunology treatments.
FDA Approval of PONLIMSI Expands Treatment Access
The FDA approval of PONLIMSI™ was based on a comprehensive data package demonstrating comparable efficacy, safety, and immunogenicity to the reference product Prolia®, reinforcing confidence in biosimilar adoption. The drug is approved for all indications of Prolia®, including treatment of osteoporosis in postmenopausal women and men at high risk of fracture, as well as glucocorticoid-induced osteoporosis and bone loss associated with cancer therapies.
This approval is expected to enhance patient access to cost-effective biologic therapies, particularly in high-burden conditions such as osteoporosis, where long-term treatment adherence is essential. By introducing a biosimilar alternative, Teva aims to reduce healthcare costs while maintaining high standards of clinical efficacy and safety, supporting broader adoption in clinical practice.
Regulatory Progress for Xolair Biosimilar Candidate
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In addition to the FDA approval milestone, Teva announced that its biosimilar candidate to Xolair® (omalizumab) has been accepted for regulatory review by both the U.S. FDA and the European Medicines Agency (EMA). The submissions include comprehensive analytical and clinical data packages, demonstrating similarity in efficacy, safety, and immunogenicity to the reference product.
The proposed biosimilar targets multiple indications, including moderate-to-severe allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and IgE-mediated food allergies, representing a significant opportunity in the immunology and respiratory therapy markets. Acceptance for review by both regulatory agencies marks a critical step toward potential global commercialization and expanded patient access.
Strategic Growth in Biosimilars and Biopharma Innovation
These milestones underscore Teva’s Pivot to Growth strategy, which focuses on building a robust pipeline of biosimilars and innovative medicines. The company’s biosimilars platform combines advanced R&D capabilities, strategic partnerships, and global manufacturing expertise, enabling the development of high-quality biologic alternatives.
By expanding its biosimilar portfolio, Teva is positioning itself to address growing demand for affordable biologic therapies, particularly in chronic and complex diseases. The company’s approach also aligns with global healthcare priorities, including improving treatment accessibility, reducing costs, and supporting sustainable healthcare systems.
With a strong pipeline and multiple regulatory milestones achieved, Teva is poised to play a significant role in shaping the future of biopharmaceutical innovation and biosimilar adoption worldwide.
Advancing Biosimilar Innovation and Access
The FDA approval of PONLIMSI and the regulatory progress of the Xolair biosimilar candidate highlight Teva’s commitment to expanding access to high-quality biologic therapies while driving innovation in the biosimilars space. These achievements mark a significant step forward in improving patient care, reducing treatment costs, and strengthening global healthcare systems.
Source: Teva Pharmaceutical press release
