Teva Pharmaceuticals announced Sept. 28 that the U.S. Food and Drug Administration approved Degevma (denosumab-adet), a biosimilar to Amgen's Xgeva. The drug is approved for all of Xgeva's uses, including preventing fractures and other bone complications in adults whose cancer has spread to the bone.
For patients with advanced breast, prostate, lung, or other solid tumors, and for people with multiple myeloma, bone complications can mean fractures, spinal cord compression, surgery, or radiation. Xgeva is one of the standard drugs used to lower that risk, and patients may receive it for months or years.
That long treatment window is why a biosimilar matters for households: more versions of the same medicine can create price competition. Teva has not announced a price, and insurance coverage will decide what any patient actually pays.
Degevma's Approved Uses and Safety Warnings
According to Teva's announcement, Degevma is approved for three uses. It can prevent skeletal-related events, such as fractures, in patients with multiple myeloma and in patients with bone metastases from solid tumors. It can treat adults and skeletally mature adolescents with giant cell tumor of bone that cannot be removed or where surgery would likely cause severe harm. It can also treat high blood calcium caused by cancer when bisphosphonate drugs have not worked.
Denosumab is a lab-made antibody that blocks a protein called RANKL, which drives the cells that break down bone. By slowing that breakdown, the drug reduces cancer-related bone damage. Degevma will come as a 120 mg/1.7 mL injection in a vial.
The safety warnings match those of the original drug. Denosumab can cause severe low blood calcium, including fatal cases, so calcium levels need monitoring. Other risks include serious allergic reactions, osteonecrosis of the jaw, unusual thigh-bone fractures, high blood calcium after treatment stops, and multiple spine fractures after treatment stops. Patients should not receive two denosumab products at the same time, and the drug can harm a developing pregnancy. People with low blood calcium need it corrected before starting treatment.
Teva said the approval was based on a "totality of evidence," including lab and clinical data showing no clinically meaningful differences from Xgeva in safety, purity, and potency. Teva's companion product, Ponlimsi, a biosimilar to the osteoporosis drug Prolia, was approved in March 2026. Degevma received marketing authorization in the European Union on Nov. 17, 2025, according to the European Medicines Agency.
Biosimilars Explained for Patients Weighing a Switch
A biosimilar is not a generic. Generics copy simple chemical drugs exactly. Biologics like denosumab are made in living cells, so a biosimilar is highly similar to the original rather than identical, and it must have no clinically meaningful differences in safety or effectiveness, according to the FDA's guide for patients.
The FDA says the approval of biosimilars "can improve access to care for patients by increasing the number of medication options and potentially lower costs." Its biosimilar product list, last updated Aug. 4, already included nine biosimilars referencing Xgeva, starting with Wyost in March 2024. Each was approved alongside a matching biosimilar referencing Prolia.
Teva's two products follow the same pattern, though they carry different brand names and were approved six months apart. For patients, the brand name on the vial matters less than the active ingredient, since every product in this group contains denosumab and carries the same core safety warnings.
The approval details come from Teva, which has a commercial interest in the product. Teva's announcement did not say whether Degevma is designated as interchangeable, a status that in many states lets a pharmacist substitute it without a new prescription. Because Xgeva is usually given in a clinic, substitution decisions are more often made by the oncology practice and the insurer than at a retail pharmacy.
"The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine," said Thomas Rainey, Teva's senior vice president for U.S. biosimilars. Independent price data will not exist until the drug launches.
Costs, Coverage, and Questions for the Care Team
Patients most likely to feel an effect are those on long-term denosumab, including people with metastatic breast or prostate cancer and multiple myeloma. Uninsured patients and people with high-deductible plans or coinsurance pay the largest share of a biologic's price, so competition matters most to them.
The practical effect will depend on insurer formularies. Some plans prefer one biosimilar, others prefer the brand, and a switch can require a new prior authorization. Medicare patients who receive the drug in a clinic should ask how it will be billed and what their share will be.
Patients currently on Xgeva should not stop or change treatment on their own. Stopping denosumab can raise the risk of spine fractures, which is why the label warns about discontinuation. Any change should be made with the prescribing oncologist.
Useful questions for the care team include which denosumab product the clinic uses, whether insurance prefers a specific version, what out-of-pocket cost to expect, and whether a manufacturer assistance program applies. A dental exam before starting therapy is also recommended because of the jaw-bone risk.
Patients should call their care team promptly about muscle spasms, numbness, or tingling, which can signal low calcium. Jaw pain, loose teeth, or new thigh, hip, or groin pain also warrant a call. Side effects can be reported to the FDA through the MedWatch safety reporting program.
Teva said it "anticipates launching DEGEVMA and PONLIMSI in the U.S. in the coming months." Pricing, insurer coverage decisions, and any interchangeability designation are the next details to watch.
Key Questions Answered
What is Degevma? Degevma (denosumab-adet) is Teva's FDA-approved biosimilar to Xgeva. It helps prevent fractures and other bone complications in people whose cancer has spread to the bone.
Who can use it? Adults with multiple myeloma or bone metastases from solid tumors, adults and skeletally mature adolescents with giant cell tumor of bone that cannot safely be removed, and patients with cancer-related high calcium that has not responded to bisphosphonates.
Is a biosimilar the same as a generic? No. A biosimilar is highly similar to a biologic made in living cells, with no clinically meaningful differences in safety or effectiveness. A generic is an exact copy of a chemical drug.
Will Degevma be cheaper than Xgeva? Teva has not announced a price. Out-of-pocket costs will depend on insurance coverage and which product a plan prefers.
Should I switch from Xgeva? Not on your own. Talk with your oncologist, because stopping denosumab can raise the risk of spine fractures.
What side effects should patients watch for? Symptoms of low calcium, such as muscle cramps or tingling, jaw pain or loose teeth, and new thigh, hip, or groin pain, should be reported to a clinician.
Published by Medicaldaily.com
