- DEGEVMA™ is now FDA-approved across all indications of the reference product, Xgeva® (denosumab), to help prevent bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone and for the treatment of hypercalcemia of malignancy.
asserted
that → approve → malignancy
- FDA approval of DEGEVMA marks another milestone in Teva’s Pivot to Growth strategy, demonstrating our ability to bring high-quality, more affordable treatment options to patients across complex therapeutic categories.
- DEGEVMA is Teva’s second FDA-approved biosimilar in 2026 and, together with PONLIMSI™ (denosumab-adet), establishes Teva’s comprehensive denosumab biosimilar portfolio across the indications of the reference products Xgeva® and Prolia® (denosumab).
asserted
DEGEVMA → mark → products
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved DEGEVMA™ (denosumab-adet) as a biosimilar to Xgeva® (denosumab).
asserted
Administration → announce → Xgeva
DEGEVMA is indicated for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone and for the treatment of hypercalcemia of malignancy.
asserted
that → indicate → malignancy
The FDA approval of DEGEVMA, together with PONLIMSI (denosumab-adet), which was approved by the FDA in March 2026, establishes a comprehensive U.S. denosumab biosimilar portfolio spanning the indications of both Xgeva® and Prolia® (denosumab), respectively.
asserted
which → approve → Xgeva
Now, healthcare professionals and patients are able to gain expanded access to biologic treatment options in oncology-related bone disease and osteoporosis care.
asserted
professionals → gain → care
“Our R&D mission is grounded in a clear commitment: translating complex biologic science into high-quality treatment options that address patient needs,” said Rob Cook, Head of Global Technical Development & Generics R&D at Teva.
asserted
Cook → ground → Teva
“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.”
asserted
approval → reflect → medicines
Biologics like denosumab represent a significant portion of healthcare expenditures, particularly in oncology.
asserted
Biologics → represent → oncology
The introduction of biosimilars is critical to driving down systemic healthcare costs while broadening patient access to complex, life-enhancing medications.
asserted
introduction → drive → medications
“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, Senior Vice President, U.S. Biosimilars at Teva.
asserted
Rainey → live → Teva
“The approval of DEGEVMA is a powerful example of Teva’s Pivot to Growth strategy in action because it represents an important step in expanding treatment options for patients and supporting healthcare systems with a high-quality biosimilar.
asserted
it → represent → biosimilar
The FDA approval of DEGEVMA was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety and immunogenicity profile as the reference product, Xgeva®.
asserted
approval → base → product
DEGEVMA is a human monoclonal antibody that binds to the RANKL protein, an essential regulator of osteoclast formation, function and survival.
asserted
that → bind → formation
By inhibiting RANKL, DEGEVMA decreases bone resorption and cancer-induced bone destruction.
asserted
DEGEVMA → inhibit → resorption
The comprehensive data package submitted to the FDA demonstrated that DEGEVMA has no clinically meaningful differences from the reference product in terms of safety, purity and potency.
asserted
DEGEVMA → submit → safety
Teva anticipates launching DEGEVMA and PONLIMSI in the U.S. in the coming months, aligning with its broader biosimilar commercialization strategy.
asserted
Teva → launch → strategy
DEGEVMA is currently approved in the European Union (EU).
asserted
DEGEVMA → approve → Union
Use of Trademarks
Xgeva® and Prolia® are registered trademarks of Amgen, Inc.
asserted
Xgeva → register → Inc.
About DEGEVMA
DEGEVMA (denosumab) is indicated for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone and for the treatment of hypercalcemia of malignancy.
asserted
that → indicate → malignancy
The active substance, denosumab, is a human monoclonal IgG2 antibody that targets the protein RANKL, essential for the formation, function, and survival of osteoclasts—the cells responsible for bone resorption.
asserted
that → target → resorption
By binding to RANKL with high affinity and specificity, denosumab prevents the interaction between RANKL and RANK, leading to a decrease in bone resorption in cortical and trabecular bone.
asserted
denosumab → bind → bone
DEGEVMA is a biosimilar medicinal product, similar to the reference product Xgeva® (denosumab), which was approved in the EU on November 18, 2025.
asserted
which → approve → November
Comprehensive analytical, preclinical, and clinical data demonstrate that DEGEVMA has comparable quality, safety and efficacy to the reference product.
asserted
DEGEVMA → demonstrate → product
INDICATIONS
DEGEVMA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
asserted
DEGEVMA → indicate → tumors
DEGEVMA is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
asserted
resection → indicate → morbidity
DEGEVMA is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
asserted
DEGEVMA → indicate → therapy
Pre-existing hypocalcemia must be corrected prior to initiating therapy with DEGEVMA.
asserted
hypocalcemia → correct → DEGEVMA
DEGEVMA is contraindicated in patients with known clinically significant hypersensitivity to DEGEVMA or denosumab products.
asserted
DEGEVMA → contraindicate → DEGEVMA
WARNINGS AND PRECAUTIONS
Drug Products with Same Active Ingredient
Patients receiving DEGEVMA should not receive other denosumab products.
asserted
Patients → receive → products
Hypersensitivity
Clinically significant hypersensitivity including anaphylaxis has been reported with use of DEGEVMA.
asserted
hypersensitivity → include → DEGEVMA
Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria.
uncertain
Reactions → include → hypotension
If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue DEGEVMA therapy permanently.
asserted
reaction → occur → therapy
Hypocalcemia
DEGEVMA can cause severe symptomatic hypocalcemia, and fatal cases have been reported.
asserted
cases → cause → hypocalcemia
Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be closely monitored.
uncertain
calcium → lower → risk
Do not take DEGEVMA if you are allergic to denosumab or any of the ingredients of DEGEVMA.
asserted
you → take → DEGEVMA
An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation.
asserted
risk → observe → supplementation
Osteonecrosis of the Jaw (ONJ)
Osteonecrosis of the jaw (ONJ) has been reported in patients receiving DEGEVMA, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion.
asserted
Osteonecrosis → report → pain
Patients with a history of tooth extraction, poor oral hygiene, or use of a dental appliance are at a higher risk of developing ONJ.
asserted
Patients → develop → ONJ
Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.
asserted
factors → include → inhibitors
…and 27 more, not listed.
The Aporia
