FDA Approves Denosumab-Adet as Biosimilar to Prolia

The FDA approved denosumab-adet (Ponlimsi) as a biosimilar to denosumab (Prolia) for all indications of the reference product, including the treatment of postmenopausal women with osteoporosis at high risk for fracture and increasing bone mass in men with osteoporosis.

“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 news release. “With a strong early-stage pipeline and a suite of advancing programs, we see significant potential to address patient needs and fuel Teva’s long-term growth.”

Beyond osteoporosis, the medication is also indicated for patients experiencing glucocorticoid-induced bone loss and those receiving certain therapies for prostate or breast cancer that increase the risk of fractures. The FDA's decision was supported by a comprehensive totality of evidence, which demonstrated that denosumab-adet maintains a similar profile of efficacy, safety, and immunogenicity to the original biologic.

For pharmacists, understanding the clinical mechanism and administrative requirements of denosumab is essential for patient management and counseling. Denosumab functions as a human IgG2 monoclonal antibody that binds to the receptor activator of NF kappa B ligand (RANKL), effectively inhibiting its interaction with the RANK receptor. This blockade prevents the maturation and survival of osteoclasts, which are the primary cells responsible for bone resorption.²

Administered strictly as a subcutaneous injection, the drug reaches a median peak concentration in approximately 10 days and has a prolonged elimination half-life of roughly 32 days. Because the effects of denosumab on bone remodeling reverse quickly if a dose is missed, pharmacists must play a vital role in ensuring patient compliance, as treatment interruptions can lead to a rebound in bone turnover and an increased risk of multiple vertebral fractures.

The FDA has included a boxed warning for denosumab-adet regarding the risk of severe hypocalcemia in patients with advanced chronic kidney disease, particularly those who are dialysis dependent. Pharmacists should be vigilant in monitoring serum calcium, phosphorus, and magnesium levels, especially within the first few weeks of treatment or in patients predisposed to mineral metabolism disturbances.^1,2

Additionally, patients should be encouraged to maintain adequate intake of calcium and vitamin D supplements. Other serious but rare adverse events that require clinical attention include osteonecrosis of the jaw and atypical subtrochanteric femoral fractures, both of which may necessitate a thorough dental or orthopedic evaluation.

The approval of denosumab-adet arrives amidst a rapidly expanding landscape for denosumab biosimilars, which aims to increase the affordability and accessibility of life-changing biologics. Although denosumab-adet joins several other approved denosumab biosimilars, such as those referencing both Prolia and Xgeva, the emergence of interchangeability status for some of these products is a major development for pharmacy practice.³

Interchangeability allows for the substitution of a biosimilar at the pharmacy level without the prior approval of the prescribing physician, depending on state laws and specific FDA designations. Teva’s recent announcement did not specify an interchangeability designation for denosumab-adet.

“The FDA approval of Ponlimsi is a significant milestone that showcases our robust clinical, analytical, operational, and regulatory expertise,” Yolanda Tibbe, global head of biosimilars at Teva, said in the news release.¹

READ MORE: Biosimilar Resource Center

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REFERENCES

1. Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab). News release. Teva. March 30, 2026. Accessed March 30, 2026. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Gains-Biosimilar-Momentum-with-U-S--FDA-Approval-of-PONLIMSI-denosumab-adet-and-Dual-Filing-Acceptance-for-Biosimilar-Candidate-to-Xolair-omalizumab/default.aspx

2. Hildebrand GK, Patel P, Kasi A. Denosumab. [Updated 2024 Feb 28]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK535388/

3. Gallagher A. FDA approves denosumab-mobz as biosimilar for Prolia, Xgeva. Drug Topics. January 5, 2026. Accessed March 30, 2026. https://www.drugtopics.com/view/fda-approves-denosumab-mobz-as-biosimilar-for-prolia-xgeva