Teva Pharmaceutical Industries has reached important milestones in its biosimilars program, reinforcing progress in its ‘Pivot to Growth’ strategy
The U.S. Food and Drug Administration (FDA) has approved PONLIMSI (denosumab-adet), a biosimilar to Prolia, for all approved uses of the reference product. In addition, regulatory applications for Teva’s proposed biosimilar to Xolair (omalizumab) have been accepted for review by both the FDA and the European Medicines Agency (EMA).
PONLIMSI is indicated for multiple bone-related conditions, including osteoporosis in postmenopausal women and men at high fracture risk, glucocorticoid-induced osteoporosis, and bone loss associated with certain cancer therapies. The approval is supported by comprehensive analytical and clinical data demonstrating comparable efficacy, safety, and immunogenicity to Prolia.
Teva leadership highlighted these developments as evidence of the company’s growing expertise in biosimilars. By combining internal research capabilities with strategic partnerships, Teva continues to build a competitive and expanding pipeline aimed at addressing unmet patient needs and supporting long-term growth.
The company previously received EMA approval for PONLIMSI in November 2025, following a positive recommendation earlier that year.
In parallel, Teva’s biosimilar candidate to Xolair is now under review in both the U.S. and Europe. The submissions include all approved indications of the reference product, such as allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and certain food allergies (U.S. only). These applications are backed by data demonstrating similarity in effectiveness, safety, and immune response.
Together, these milestones underscore Teva’s commitment to expanding access to biologic treatments through a robust and growing biosimilars portfolio.
For more information, visit https://www.tevapharm.com/
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