FDA Approved New Biosimilar for Bone Complications
Adults with advanced cancer or specific bone tumors may soon have a new treatment option available.
Updated on Sept. 28, 2026 in Cancer
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The FDA has approved DEGEVMA, a biosimilar to the medication Xgeva, to help prevent bone complications in adults with advanced cancer. The product is also indicated for treating adults and adolescents with giant cell tumor of bone and hypercalcemia of malignancy.
Why it matters
This approval provides a new biosimilar option for patients managing bone-related side effects, potentially increasing treatment access. It is part of a broader shift toward using biosimilars to manage chronic conditions.
The FDA approval was based on analytical and clinical data showing DEGEVMA has similar safety, efficacy, and immunogenicity to the reference product Xgeva. The study results supported the use of this monoclonal antibody for its specific indicated conditions.
The players
Teva
A global pharmaceutical company that develops generic and biosimilar medications for various therapeutic areas.
FDA
The federal agency responsible for protecting public health by ensuring the safety and efficacy of medications and medical products.
The details
DEGEVMA is a human monoclonal antibody that functions by binding to the RANKL protein. By preventing the interaction between RANKL and its receptor, RANK, the medication decreases bone resorption and helps stabilize bone health in patients with advanced malignancies or specific tumors.
Timeline
November 18, 2025: DEGEVMA received approval in the European Union.
March 2026: The FDA approved the biosimilar PONLIMSI.
September 28, 2026: The FDA approved DEGEVMA in the U.S.
Coming months: Teva plans to launch DEGEVMA and PONLIMSI in the U.S.
Health Landscape
The approval of DEGEVMA marks another step in the expansion of the FDA's biosimilar development and approval program, which aims to provide cost-effective alternatives to established biologics. This trend continues the growth of the biosimilar market as a standard component of modern oncology care.
If you are currently managing bone health related to advanced cancer or a giant cell tumor, this approval may soon offer a new option for your care plan. It is worth discussing with your doctor whether a biosimilar is appropriate for your treatment goals.
The takeaway
The FDA's approval of DEGEVMA adds a new biosimilar tool for treating bone complications in cancer patients. Patients and caregivers should track upcoming availability of this medication and discuss potential treatment changes with their oncology team.
What happens next
Teva plans to launch DEGEVMA and PONLIMSI in the U.S. in the coming months.
Further reading
Learn more about new developments in oncology care in our Cancer section.
More information
For information on monitoring medication safety, visit the FDA adverse reaction reporting page.
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