Teva Pharmaceutical Industries Ltd. received U.S. Food and Drug Administration approval for its denosumab‑adet biosimilar, PONLIMSI, covering all indications of the reference product Prolia, including post‑menopausal osteoporosis, glucocorticoid‑induced osteoporosis, and bone loss associated with androgen‑deprivation or aromatase inhibitor therapy.
In parallel, Teva’s Xolair biosimilar candidate was accepted by both the FDA and the European Medicines Agency for all indications of the reference product, such as moderate‑to‑severe allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and IgE‑mediated food allergies.
These approvals reinforce Teva’s Pivot to Growth strategy, which has driven consecutive years of growth and aims for a 30% non‑GAAP operating margin by 2027. By adding PONLIMSI and the Xolair biosimilar to its pipeline, Teva expands its specialty‑pharma portfolio and strengthens its competitive moat in high‑margin markets.
The approvals come after Teva’s FY 2025 results, where revenue rose to $17.3 billion—a 4% year‑over‑year increase—and non‑GAAP earnings per share reached $2.93. The company’s focus on high‑margin specialty products has been a key driver of that growth, and the new biosimilars are expected to accelerate that trajectory.
Management has highlighted the importance of the Pivot to Growth strategy. In the Q4 2025 earnings release, CEO Richard Francis noted that the strategy had driven the third consecutive year of growth, solidifying Teva’s transformation into a leading biopharmaceutical company.
Analysts have expressed confidence in Teva’s trajectory following the recent performance and the new approvals, which are expected to further support investor confidence.
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