The U.S. Food and Drug Administration approved denosumab-adet as a biosimilar to denosumab, expanding treatment options for osteoporosis and bone loss. The drug is approved for all the same uses as Prolia, including treating osteoporosis in high-risk men and postmenopausal women, managing bone loss caused by long-term steroid use, and increasing bone mass in patients receiving hormone therapies for prostate or breast cancer.
Ponlimsi carries important safety warnings. Patients with advanced kidney disease or those on dialysis have a higher risk of severe low calcium levels. It should not be used in patients with existing hypocalcemia, during pregnancy, or in those allergic to denosumab products. Other risks include jaw bone damage, unusual thigh fractures, and serious infections.
The approval is based on strong evidence showing that Ponlimsi matches Prolia in effectiveness, safety, and immune response. This decision follows earlier approval in Europe and supports Teva Pharmaceuticals’s growing biosimilar portfolio.