FDA Approves Teva Biosimilar for Denosumab in Osteoporosis

Denosumab-adet (Ponlimsi; Teva Pharmaceutical Industries) was approved by the FDA as a biosimilar to treat postmenopausal women with osteoporosis, in addition to all other indications of the reference product, Prolia (denosumab; Amgen Inc).1

The approval of denosumab-adet was based on evidence that demonstrated a similar efficacy, safety, and immunogenicity profile compared with the originator. Denosumab-adet is also approved to treat postmenopausal women with osteoporosis with a high risk of fracture to increase bone mass, women with a high risk of fracture receiving adjuvant aromatase inhibitor therapy for breast cancer to increase bone mass, men with osteoporosis with a high risk of fracture, and men with a high risk of fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.

The European Medicines Agency (EMA) granted Teva marketing authorization for denosumab-adet in November 2025 after a positive review from the Committee for Medicinal Products for Human Use in early 2025.1

Denosumab products are human monoclonal antibodies that bind to RANKL, preventing RANK receptors on the surface of osteoclasts from activating and causing osteoclastic bone reabsorption.

There are more than 10 million adults in the US over the age of 50 with osteoporosis, of whom more than 80% are women. Approximately 1 in 2 women and 1 in 4 men will experience an osteoporosis-related fracture, decreasing quality of life and increasing the likelihood of disability and death.2

The approval of denosumab-adet adds to a growing list of denosumab biosimilars expanding access in a competitive landscape for biosimilar therapies targeting bone health and cancer-related skeletal events.3

Commonly reported adverse events with denosumab products—occurring in more than 5% of patients taking them for postmenopausal osteoporosis and more common than placebo—included back pain, pain in the extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.1

The most common adverse reactions reported in men with osteoporosis—accounting for more than 5% of patients—were back pain, arthralgia, and nasopharyngitis.

Additionally, Teva’s applications for a proposed biosimilar to the reference product Xolair (omalizumab; Novartis AG) were accepted by the US FDA and the EMA to treat allergic asthma.1

Xolair is a humanized monoclonal antibody targeting IgE, preventing it from activating cells that trigger allergic reactions. Allergic asthma is the most common form of asthma. Individuals with allergic asthma can be triggered by harmless substances, causing the airways of the lungs to become inflamed and swollen. Adverse events include coughing, wheezing, shortness of breath, and tightness in the chest.

“Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we’re building a highly competitive portfolio,” Steffen Nock, PhD, head of biosimilars research and development and chief science officer at Teva, said in a press release.

Biosimilars are expected to play an increasingly important role in improving affordability and access to biologic therapies in the US. By introducing lower-cost alternatives to reference products, biosimilars may help reduce overall health care spending while expanding treatment availability. For payers and providers, the growing availability of biosimilars also introduces new considerations around formulary placement, interchangeability, and patient access strategies.3

Together, these developments bring “significant potential to address patient needs and fuel Teva’s long-term growth,” Nock said.

References

1. Teva gains biosimilar momentum with U.S. FDA approval of PONLIMSI (denosumab-adet) and dual filing acceptance for biosimilar candidate Xolair (omalizumab). News release. Teva. March 31, 2026. Accessed March 31, 2026. https://www.tevapharm.com/news-and-media/latest-news/teva-gains-biosimilar-momentum-with-u.s.-fda-approval-of-ponlimsi-denosumab-adet-and-dual-filing-accep

2. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars®. March 5, 2024. Accessed March 31, 2026. https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

3. Jeremias S. FDA quietly approves denosumab biosimilars, issues interchangeability for others. The Center for Biosimilars. November 13, 2025. Accessed March 31, 2026. https://www.centerforbiosimilars.com/view/fda-quietly-approves-denosumab-biosimilars-issues-interchangeability-for-others