Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab)
- Teva's biosimilar, PONLIMSI™, is now FDA-approved across all indications of the reference product, Prolia® (denosumab), to treat a variety of debilitating bone conditions.
- Teva's proposed biosimilar candidate to Xolair® (omalizumab) is accepted for review by U.S. FDA and EU EMA.
- These milestones demonstrate Teva's biosimilars expertise and are a significant step in Teva's Pivot to Growth strategy, highlighting its transformation into a leading biopharmaceutical company with a broad biosimilars portfolio.
TEL AVIV, Israel and PARSIPPANY, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. The United States (U.S.) Food and Drug Administration (FDA) has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia®, and Teva's applications for a proposed biosimilar candidate to Xolair® (omalizumab) have been accepted by both the U.S. FDA and the European Medicines Agency (EMA).
“Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we're building a highly competitive portfolio," said Steffen Nock, PhD, Head of Biosimilars R&D and Chief Science Officer at Teva. “With a strong early-stage pipeline and a suite of advancing programs, we see significant potential to address patient needs and fuel Teva's long-term growth.”
PONLIMSI FDA Approval
The FDA approval of PONLIMSI was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety, and immunogenicity profile as the reference product, Prolia®. PONLIMSI is approved for all indications of the reference product Prolia®, which include treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
“The FDA approval of PONLIMSI is a significant milestone that showcases our robust clinical, analytical, operational and regulatory expertise,” said Yolanda Tibbe, Global Head of Biosimilars at Teva. “To receive U.S. FDA approval of PONLIMSI and the filing acceptances of our proposed biosimilar candidate to Xolair® in the U.S. and Europe truly underscores the strength of our expanding global biosimilar portfolio and reaffirms our commitment to expand treatment options for patients.”
The European Medicines Agency (EMA) granted marketing authorization for Teva's denosumab biosimilar candidate PONLIMSI, a biosimilar to Prolia® in November 2025, following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) earlier in the year.
Filing Acceptances of Proposed Biosimilar Candidate to Xolair® (omalizumab)
The regulatory submissions for the biosimilar candidate to Xolair® (omalizumab) consist of a Biologics License Application (BLA) to the U.S. FDA and a Marketing Authorization Application (MAA) in the European Union (EU) to the EMA. Both applications include all indications approved for the reference product, Xolair®– moderate-to-severe (U.S.)/severe (EU) persistent allergic asthma (ages 6+), chronic rhinosinusitis with nasal polyps (adults 18+), chronic spontaneous urticaria (ages 12+) and, in the U.S., IgE-mediated food allergies (ages 1+). These regulatory applications are supported by a comprehensive data package that includes analytical and clinical data on efficacy, safety and immunogenicity similar to Xolair® (omalizumab).
Learn more about Teva's global biosimilars portfolio and commercialization capabilities at www.tevabiosimilars.com.
Use of Trademarks
Prolia® is a registered trademark of Amgen, Inc.
Xolair® is a registered trademark of Novartis AG.
INDICATIONS
PONLIMSI is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures.
PONLIMSI is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
PONLIMSI is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
PONLIMSI is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients denosumab also reduced the incidence of vertebral fractures.
PONLIMSI is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
IMPORTANT SAFETY INFORMATION
WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
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CONTRAINDICATIONS
PONLIMSI is contraindicated in:
- Patients with hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with PONLIMSI.
- Pregnant women: Denosumab products may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with PONLIMSI.
- Patients with hypersensitivity to denosumab products: PONLIMSI is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling, and urticaria.
WARNINGS AND PRECAUTIONS
Severe Hypocalcemia and Mineral Metabolism Changes
Denosumab products can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with PONLIMSI. Adequately supplement all patients with calcium and vitamin D. In patients without advanced chronic kidney disease who are predisposed to hypocalcemia and disturbances of mineral metabolism (e.g., history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, excision of small intestine, treatment with other calcium-lowering drugs), assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after PONLIMSI injection.
Patients with Advanced Chronic Kidney Disease
Patients with advanced chronic kidney disease [i.e., eGFR <30 mL/min/1.73 m2] including dialysis-dependent patients are at greater risk for severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. The presence of underlying chronic kidney disease-mineral bone disorder (CKD-MBD, renal osteodystrophy) markedly increases the risk of hypocalcemia. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk.
To minimize the risk of hypocalcemia in patients with advanced chronic kidney disease, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25 (OH)2 vitamin D prior to decisions regarding PONLIMSI treatment. Consider also assessing bone turnover status (serum markers of bone turnover or bone biopsy) to evaluate the underlying bone disease that may be present. Monitor serum calcium weekly for the first month after PONLIMSI administration and monthly thereafter. Instruct all patients with advanced chronic kidney disease, including those who are dialysis-dependent, about the symptoms of hypocalcemia and the importance of maintaining serum calcium levels with adequate calcium and activated vitamin D supplementation. Treatment with PONLIMSI in these patients should be supervised by a healthcare provider who is experienced in diagnosis and management of CKD-MBD.
Drug Products with Same Active Ingredient
Patients receiving PONLIMSI should not receive other denosumab products concomitantly.
Hypersensitivity
Clinically significant hypersensitivity including anaphylaxis has been reported with denosumab products. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of PONLIMSI.
Osteonecrosis of the Jaw (ONJ)
ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing. ONJ has been reported in patients receiving denosumab products. A routine oral exam should be performed by the prescriber prior to initiation of PONLIMSI treatment. A dental examination with appropriate preventive dentistry is recommended prior to treatment with PONLIMSI in patients with risk factors for ONJ such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and comorbid disorders. Good oral hygiene practices should be maintained during treatment with PONLIMSI. The risk of ONJ may increase with duration of exposure to denosumab products.
For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit-risk assessment.
Patients who are suspected of having or who develop ONJ while on PONLIMSI should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of PONLIMSI therapy should be considered based on individual benefit-risk assessment.
Atypical Subtrochanteric and Diaphyseal Femoral Fractures
Atypical low energy or low trauma fractures of the shaft have been reported in patients receiving denosumab products. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents.
During PONLIMSI 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. Interruption of PONLIMSI therapy should be considered, pending a benefit-risk assessment, on an individual basis.
Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment
Following discontinuation of denosumab products, fracture risk increases, including the risk of multiple vertebral fractures. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of denosumab. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab discontinuation. Evaluate an individual's benefit-risk before initiating treatment with PONLIMSI. If PONLIMSI treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy.
Serious Infections
In a clinical trial of over 7,800 women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in PONLIMSI than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with denosumab. Endocarditis was also reported more frequently in denosumab-treated patients. The incidence of opportunistic infections was similar between placebo and denosumab groups, and the overall incidence of infections was similar between the treatment groups. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis.
Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. In patients who develop serious infections while on PONLIMSI, prescribers should assess the need for continued PONLIMSI therapy.
Dermatologic Adverse Reactions
Epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate with denosumab products compared to the placebo group. Most of these events were not specific to the injection site. Consider discontinuing PONLIMSI if severe symptoms develop.
Musculoskeletal Pain
Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking denosumab products. The time to onset of symptoms varied from one day to several months after starting denosumab products. Consider discontinuing use if severe symptoms develop.
Suppression of Bone Turnover
In clinical trials in women with postmenopausal osteoporosis, treatment with denosumab resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance of these findings and the effect of long-term treatment with denosumab products are unknown. Monitor patients for these consequences.
Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta
PONLIMSI is not approved for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products. Some cases required hospitalization.
ADVERSE REACTIONS
The most common adverse reactions (> 5% and more common than placebo) reported with denosumab products in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.
The most common adverse reactions (> 5% and more common than placebo) reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis.
The most common adverse reactions (> 3% and more common than placebo) reported with denosumab products in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache.
The most common (per patient incidence ≥10%) adverse reactions reported with denosumab products in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
The most common adverse reactions leading to discontinuation of denosumab products in patients with postmenopausal osteoporosis are back pain and constipation.
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 click here for full Prescribing Information for PONLIMSI, including BOXED WARNINGS.
About Teva's Proposed Biosimilar Candidate to Xolair® (omalizumab)
Teva's proposed biosimilar candidate to Xolair® (omalizumab) is a humanized monoclonal antibody that targets IgE. By preventing IgE from activating the cells that cause allergic reactions, it could help to control or reduce symptoms that could stop the reaction before it starts. Teva's proposed biosimilar candidate is an investigational product and has not received regulatory approval in any country at this time.
About Allergic Asthma
Allergic asthma is the most common form of asthma, a chronic respiratory condition characterized by inflammation of the airways.1 In individuals with allergic asthma, exposure to otherwise harmless substances triggers a complex reaction that causes the passages in the airways of the lungs to become inflamed and swollen.1 This makes it difficult for air to move in and out of the lungs, causing symptoms such as coughing, wheezing, shortness of breath and/or chest tightness.
About Chronic Rhinosinusitis with Nasal Polyps
Chronic rhinosinusitis, also referred to as chronic sinusitis, is a long-term inflammatory condition of the nasal passages and sinuses lasting 12 weeks or more.2 It is characterized by the presence of soft, non-cancerous growths called nasal polyps.3 These polyps can vary in size and, when large or numerous, can block the nasal passages, leading to a variety of symptoms and impacting a person's quality of life.3
About Chronic Spontaneous Urticaria
Chronic spontaneous urticaria is a condition characterized by the recurrence of hives (urticaria), deep skin swelling (angioedema) or both, for six weeks or longer, without an identifiable external trigger.4 Itchy skin and the recurrent rashes cause high quality-of-life issues.
About IgE-Mediated Food Allergies
IgE-mediated food allergies cause the immune system to react abnormally quickly when exposed to one or more specific foods, such as milk, egg, wheat or nuts.5 Reactions are caused by the IgE antibody and can cause multiple symptoms across the body, that are sometimes very serious.5 Avoidance of the food that causes the allergy is key but cannot fully prevent accidental exposure.
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,” “target,” “may,” “project,” “guidance,” “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 PONLIMSI (denosumab-adet) for the treatment of osteoporosis and preventing fractures in both men and women; our ability to successfully develop and commercialize our biosimilar candidate to Xolair® (omalizumab) for the treatment of persistent allergic asthma (ages 6+), chronic rhinosinusitis with nasal polyps (adults 18+), chronic spontaneous urticaria (ages 12+) and, in the U.S., IgE-mediated food allergies; 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 Annual Report on Form 10-K for the year ended December 31, 2025, including in the section captioned “Risk Factors.” 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.
This press release is intended for global, non-country specific audiences.
References:
- American Academy of Allergy, Asthma & Immunology (AAAAI). (n.d.). Asthma. https://www.aaaai.org/conditions-and-treatments/asthma
- American Academy of Allergy, Asthma & Immunology (AAAAI). (n.d.). Sinusitis. https://www.aaaai.org/conditions-treatments/allergies/sinusitis
- American Academy of Allergy, Asthma & Immunology (AAAAI). (n.d.). Nasal Polyps. https://www.aaaai.org/tools-for-the-public/conditions-library/allergies/nasal-polyps
- American Academy of Allergy, Asthma & Immunology (AAAAI). (n.d.). Hives (Urticaria) and Angioedema Overview. https://www.aaaai.org/tools-for-the-public/conditions-library/allergies/hives-(urticaria)-and-angioedema-overview
- Children's Hospital of Philadelphia. (2024). IgE-Mediated Food Allergies. https://www.chop.edu/conditions-diseases/ige-mediated-food-allergies#:~:text=IgE%2Dmediated%20food%20allergies%20cause,minutes%20to%20a%20few%20hours.
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