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 Patients with advanced chronic kidney disease (eGFR 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 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 .