The FDA has approved Degevma (denosumab-adet), a biosimilar to Xgeva (denosumab), for use in treating bone-related complications among cancer patients. The drug is authorized for adults and skeletally mature adolescents with giant cell tumor of bone, as well as hypercalcemia of malignancy.
Teva announced the approval on Monday after a review confirmed that Degevma matches Xgeva in terms of purity, potency, and safety profiles. “The approval of Degevma reflects the scientific, clinical and regulatory expertise behind our in-house biosimilars capabilities and our continued focus on expanding access to important biologic medicines.”
The company plans to launch Degevma alongside Ponlimsi, its biosimilar to Prolia, which received approval in March 2026 for osteoporosis treatment. Together, these two drugs will cover denosumab’s full range of applications, including oncology-related bone disease and osteoporosis, further solidifying Teva’s market position in the biosimilars sector.
“The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine,” added Thomas Rainey, senior vice president, U.S. Biosimilars at Teva.
Biosimilars have already contributed $81.6 billion in U.S. healthcare savings since 2015, according to Cardinal Health’s 2026 report. Of that total, $56 billion flowed directly to the healthcare system. The launch of Degevma could drive additional cost reductions, as biosimilars typically enter the market at prices around half those of their reference biologics.
However, the biosimilars market continues to face obstacles. The Office of the Assistant Secretary for Planning and Evaluation has identified physician and patient adoption, patent litigation, and interchangeability status as major challenges. Teva will need to address these issues as it introduces Degevma and Ponlimsi to the market.
This approval aligns with a broader industry trend: over the next decade, more than $230 billion in value from biologic originators is expected to lose patent protection, presenting significant opportunities for biosimilars. Teva has positioned itself to take advantage of this shift by using its commercial infrastructure and global supply chain to streamline adoption and expand patient access.
