Teva Continues Biosimilar Momentum with U.S. FDA Approval of DEGEVMA™ (denosumab-adet), a Biosimilar to Xgeva® (denosumab)

• 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.
• 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).
  
  

TEL AVIV, Israel, and PARSIPPANY, N.J., Sept. 28, 2026 (GLOBE NEWSWIRE) -- 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). 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.

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. Now, healthcare professionals and patients are able to gain expanded access to biologic treatment options in oncology-related bone disease and osteoporosis 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. “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.”

Biologics like denosumab represent a significant portion of healthcare expenditures, particularly in oncology. The introduction of biosimilars is critical to driving down systemic healthcare costs while broadening patient access to complex, life-enhancing 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. “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.”

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^®. DEGEVMA is a human monoclonal antibody that binds to the RANKL protein, an essential regulator of osteoclast formation, function and survival. By inhibiting RANKL, DEGEVMA decreases bone resorption and cancer-induced bone destruction. 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.

Teva anticipates launching DEGEVMA and PONLIMSI in the U.S. in the coming months, aligning with its broader biosimilar commercialization strategy.

DEGEVMA is currently approved in the European Union (EU). Learn more about Teva’s global biosimilars portfolio and commercialization capabilities at www.tevabiosimilars.com.

Use of Trademarks
Xgeva^® and Prolia^® are registered trademarks of Amgen, 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.

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. 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.

DEGEVMA will be available as a 120mg/1.7mL solution for injection in a vial.

DEGEVMA is a biosimilar medicinal product, similar to the reference product Xgeva^® (denosumab), which was approved in the EU on November 18, 2025.

Comprehensive analytical, preclinical, and clinical data demonstrate that DEGEVMA has comparable quality, safety and efficacy to the reference 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.

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.

DEGEVMA is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Pre-existing hypocalcemia must be corrected prior to initiating therapy with DEGEVMA.

DEGEVMA is contraindicated in patients with known clinically significant hypersensitivity to DEGEVMA or denosumab products.

WARNINGS AND PRECAUTIONS
Drug Products with Same Active Ingredient
Patients receiving DEGEVMA should not receive other denosumab products.

Hypersensitivity
Clinically significant hypersensitivity including anaphylaxis has been reported with use of DEGEVMA. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue DEGEVMA therapy permanently.

Hypocalcemia
DEGEVMA can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct pre-existing hypocalcemia prior to DEGEVMA treatment. Monitor calcium levels, throughout DEGEVMA therapy, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be closely monitored. Advise patients to contact a healthcare provider for symptoms of hypocalcemia. Do not take DEGEVMA if you are allergic to denosumab or any of the ingredients of 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. Monitor calcium levels and calcium and vitamin D intake.

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. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure. Patients with a history of tooth extraction, poor oral hygiene, or use of a dental appliance are at a higher risk of developing ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.

Perform an oral examination and appropriate preventive dentistry prior to the initiation of DEGEVMA and periodically during DEGEVMA therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with DEGEVMA. Consider temporary discontinuation of DEGEVMA therapy if an invasive dental procedure must be performed.

Patients who are suspected of having or who develop ONJ while on DEGEVMA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

Atypical Subtrochanteric and Diaphyseal Femoral Fracture
Atypical femoral fracture has been reported with DEGEVMA. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral, and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture.

During DEGEVMA treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of DEGEVMA therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons
Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in DEGEVMA-treated patients with giant cell tumor of bone and patients with growing skeletons. Within the first year after treatment discontinuation, monitor patients for signs and symptoms of hypercalcemia and treat appropriately.

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation
Multiple vertebral fractures (MVF) have been reported following discontinuation of treatment with denosumab products. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures.

When DEGEVMA treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.

Embryo-Fetal Toxicity
Based on data from animal studies and its mechanism of action, denosumab products can cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential that exposure to DEGEVMA during pregnancy or within 5 months prior to conception can result in fetal harm.

ADVERSE REACTIONS
The most common adverse reactions in patients with bone metastases from solid tumors taking DEGEVMA were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious side effect was dyspnea.

In patients with multiple myeloma, the most common adverse reactions were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious side effect of DEGEVMA was osteonecrosis of the jaw.

To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for DEGEVMA.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Teva Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “may,” “project,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully commercialize DEGEVMA (denosumab-adet) a Biosimilar to Xgeva^® (denosumab) 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, and PONLIMSI (denosumab-adet); our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the section captioned “Risk Factors” and “Forward-looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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