Efficacy and Safety of Omalizumab in Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis (ABPA): A Multicenter, Randomized, Single‑Blind, Placebo‑Controlled Clinical Study

Start Date01 Apr 2026

Sponsor / Collaborator

The First Affiliated Hospital of Ningbo University

NCT07059091

/ RecruitingPhase 2IIT

Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)

This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies.
Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.

Start Date12 Feb 2026

Sponsor / Collaborator

The Johns Hopkins University

[+3]

ChiCTR2600121306

/ RecruitingPhase 4IIT

Exploratory Study on the Combination of Selenium Nanoparticle Capsules and Omalizumab in the Treatment of Chronic Urticaria

Start Date09 Feb 2026

Sponsor / Collaborator

Nanfang Hospital

100 Clinical Results associated with Omalizumab

100 Translational Medicine associated with Omalizumab

100 Patents (Medical) associated with Omalizumab

3,976

Literatures (Medical) associated with Omalizumab

31 Dec 2026·ANNALS OF MEDICINE

Beyond biomarkers: the role of clinical factors associated with biologic therapy response in severe asthma

Article

Author: Lopez-Rodríguez, Raquel ; Cañas, José Antonio ; Rial, Manuel Jorge ; Mahíllo-Fernández, Ignacio

BACKGROUND:

Severe asthma carries a high burden and often requires biologic therapy targeting type 2 (T2) inflammation. However, treatment response is heterogeneous, and traditional biomarkers, such as blood eosinophils, fractional exhaled nitric oxide (FeNO), and total serum IgE, may not fully explain this variability .

OBJECTIVE:

To evaluate clinical and inflammatory characteristics associated with response to biologic therapies in a real-world cohort of severe asthma patients.

METHODS:

A single-center, ambispective observational study was conducted in the Allergology Department of A Coruña, Spain. Sixty-seven patients with severe uncontrolled asthma and treated with omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab, were included. Patients were followed for ≥12 months. Clinical variables and inflammatory biomarkers were assessed at baseline, 4-6 months, and 12 months. Comparisons between biologic subgroups and logistic regression analyses were performed to identify factors associated with response.

RESULTS:

Female sex, nasal polyposis, elevated blood eosinophils, and frequent exacerbations were associated with better response to biologics. Clinical factors such as nasal polyposis and aspirin-exacerbated respiratory disease (AERD) showed a stronger association with treatment response than standard biomarkers (FeNO, blood eosinophils). The mean diagnostic delay was 12.1 years, suggesting a potential influence on therapeutic results.

CONCLUSION:

Beyond traditional biomarkers, clinical factors particulary nasal polyposis and AERD may play a key role in understanding response patterns to biologics. Incorporating these variables into clinical assessment may help support a more personalized management approach in severe asthma.

01 Apr 2026·RESPIRATORY MEDICINE

Mapping the global landscape of biologics in allergic diseases: A bibliometric analysis

Review

Author: Yang, Jundong ; Xing, Yuhan ; Li, Yuanxia ; Li, Zhaoyinqian ; Yang, Jing

BACKGROUND:

Allergic diseases represent a significant global health burden. Beyond traditional treatments, which have limitations, biologics provide targeted, effective add-on therapies. However, despite its importance, the research landscape of allergy biologics has not been thoroughly examined.

METHODS:

English publications were collected from Web of Science, Scopus, and PubMed. After screening, 4141 research articles published between 1981 and 2024 were analyzed using Python, Tableau, and Gephi.

RESULTS:

Our results support the growing relevance of biologics in the treatment of allergic diseases. The volume of publications has witnessed a 25-fold increase since 2001. International collaboration has also accelerated substantially since 2015. The United States led in English research output, with the University of California system being the most prolific institution and Novartis as the largest funder. The Journal of Allergy and Clinical Immunology was the most cited journal. Simpson, E.L. and Pirozzi, G. were the most prolific and most cited authors, respectively. Keyword analysis revealed four major research clusters: 1) eczema and dupilumab, 2) asthma and omalizumab, 3) severe asthma and biologic, as well as 4) food allergy and monoclonal-antibody. Keyword bursts pinpointed eczema, dupilumab, and upadacitinib as dominant research hotspots as of 2024.

CONCLUSIONS:

Our study reveals rapid growth in research on allergy biologics, characterized by expanding global collaborations, distinct thematic communities, and emerging topics on targeted therapies for atopic conditions. While the findings primarily reflect trends in English publications, the prominent research themes and patterns provide an informative framework for future research, collaboration, and next-generation therapies.

01 Mar 2026·Biotechnology Journal

CHO Cell Line Selection through Multi‐Criteria Analysis Reveals Critical Impact of Gas Overlay

Article

Author: Corbeil, Christopher ; Sulea, Traian ; Komsalov, Petko ; Leroy, Julien ; Henry, Olivier ; Durocher, Yves ; Pham, Phuong Lan ; Cass, Brian ; Kuipers, Jason ; Gaudreault, Jimmy ; Joubert, Simon ; Lemire, Lucas ; Lamoureux, Linda ; Voyer, Robert

ABSTRACT:

The development of robust Chinese Hamster Ovary (CHO) cell lines expressing high titers of monoclonal antibodies (MAbs) is central to bioprocess development. Following transfection and pool generation, clone selection is critical, as individual clones often behave differently in stirred‐tank bioreactors.We propose a multivariate data analysis (MVDA) approach for clone selection that integrates productivity, growth, expression stability, and metabolism, with adaptable weighting based on process priorities. This method was applied to in‐house data from CHO clones producing omalizumab. From 24 candidates, eight stable, high‐performing clones were advanced for evaluation in 0.75–1 L bioreactors. MVDA revealed that including stability and metabolic parameters alters the ranking of lead clones compared with conventional screening. To assess scalability, cultures were run with or without air overlay to modulate dissolved CO 2 . Cultures without overlay reached up to 25% pCO 2 (190 mmHg) and unexpectedly showed improved performance: 1.69‐fold higher titer, 1.43‐fold greater cell‐specific productivity, 1.11‐fold higher peak cell density, extended viability, and sustained product accumulation over 17–21 days. By integrating statistical tools and a historical dataset, our MVDA method identified a robust lead clone performing consistently across CO 2 conditions, supporting its application in early upstream bioprocess development.

328

News (Medical) associated with Omalizumab

01 Apr 2026

·endpoints.news

How pharma is capitalizing on the sudden revival and success of an old asthma drug

Peanut bans at schools. EpiPen training at summer camps. Parents struggling to find an alternative to PB&J. The massive rise in food allergies transformed how many American children grow up. But a combination of better biological understanding, and a new use of an old drug, has opened up a potentially huge market in biopharma — and effective treatments for patients. It’s turned Xolair, a 23-year-old asthma medicine, into a blockbuster after it won expanded approval in 2024 to treat food allergies. Since then, sales of Xolair have jumped from under $2 billion annually to more than $4 billion. Cash has started flooding into startups, with Merida Biosciences , Excellergy and Poplar Therapeutics all emerging from stealth over the last 12 months, raising a combined $241 million in their respective Series A rounds. And big pharma is ready to engage, too. Already this year, GSK acquired RAPT Therapeutics for $1.9 billion upfront to get its allergy drug ozureprubart; Novartis, seeking to bridge the incoming Xolair cliff, bought out six-month-old Excellergy last week for up to $2 billion; and Regeneron has added allergic programs for food, cats and birch tree pollen as well. The resurgence suggests a clear and eager demand among patients and families for new treatments. If other companies can develop better and longer-lasting allergy drugs, profits should follow and patients should benefit. “Before there was more of a notion that you could avoid certain foods,” said Angelika Jahreis, Novartis’ global head of immunology development. “But now we understand how serious the consequences can be, how cumbersome it is, and how many patients have multi-allergy, allergic diseases, and that they cannot just avoid allergens.” In 2024, the CDC estimated about 18 million adults and four million children reported an allergy to at least one food. The burgeoning competition comes with an unusual circumstance: The first Xolair biosimilar hit the market last year, and more are expected to launch in 2026. Should the newer treatments work, they’d be competing against cheap generics rather than other prescription drugs. Next comes the hard part: The companies’ drugs need to succeed in clinical trials. Such an emphatic sales uptick since 2024 begs an important question: Why did Novartis and Genentech, the Roche subsidiary that originally co-developed Xolair, wait so long to seek approval in food allergy? The 20-year gap between Xolair’s approvals can be attributed first and most significantly to the FDA’s reluctance to expose children to severe allergic reactions, said Robert Wood, a professor of pediatric allergy and immunology at Johns Hopkins. In the early 2000s, such studies often involved exposing kids to peanuts to see how much allergen they could tolerate before having a serious reaction, a “challenge study” similar to how some vaccines are developed. “The FDA, at that point, made clear to them that a food challenge outcome would not ever get them an approval,” Wood said. It was too risky. That same year, Genentech canceled a food allergy study after two children in the trial apparently suffered severe responses while taking allergy tests, according to a Wall Street Journal report from the time. With the FDA’s position and the trial’s issues, the company’s leadership got “really cold feet,” Wood said. “They literally just lost interest in bringing [Xolair] forward for food allergy.” The tide started to turn in 2012, when Wood and his Johns Hopkins colleagues won an NIH grant to test Xolair in a challenge study for food allergy. The trial showed patients could tolerate significantly more exposure to peanuts after taking Xolair for six months. That NIH trial alleviated some of the FDA’s concerns over food challenge studies. Regulators then opened the door to approvals when, in 2020, a California biotech called Aimmune Therapeutics won FDA approval for its treatment Palforzia — described as a daily, oral immunotherapy to treat severe peanut allergies. “If you’re doing a study in cholesterol lowering, there’s a clear endpoint, right? For food allergy, there was no endpoint,” said Mike Dybbs, a partner at Samsara BioCapital, which invested in Excellergy. “I give Aimmune a lot of credit for working with the FDA to create a registration path.” Each dose of Palforzia contained 600 mg of peanut protein (equivalent to about two peanuts) and patients in the study had a 67% chance of avoiding a severe reaction. The company was quickly snapped up by Nestlé for $2.6 billion. This, plus Wood’s research, helped set the stage not only for Xolair’s food allergy approval but also for other companies looking to develop competitors. While companies were working through the regulatory issues, researchers were getting a much better understanding of the biology behind Xolair and allergies more broadly. Most food allergies occur when the body’s immune system mistakenly identifies an allergen as a foreign invader and activates an antibody called immunoglobulin E, or IgE, to attack it. IgE once played a pivotal role in humans’ defense against parasites, but now that most parasites are uncommon in the developed world, this activation can lead the immune system to overreact to everyday foods and airborne allergens. Originally approved for patients with allergic asthma, Xolair targets and binds to the free-flowing IgE circulating in the bloodstream, which causes the condition’s hallmark inflammation. Researchers and clinicians also realized Xolair’s cancer risk — its label included a warning for an increase in primary malignancies — was not as serious as originally thought. The biotechs that have emerged to create Xolair successors are also trying to leverage this biology. But they’re doing so with a range of approaches. Merida, which put together the biggest raise at $121 million in April 2025, wants its treatment to not only bind to free-flowing IgE, as Xolair does, but to degrade it quickly, producing a faster response, chief scientific officer Dario Gutierrez told Endpoints. “The half-life of IgE, naturally in patients, is a couple days. Xolair increases the half-life to [about] 20 days,” Gutierrez said. Merida, on the other hand, “is specifically trying to attach itself to the free-flowing IgE and then destroy it before it can be recycled.” Excellergy wants its drugs to also separate the IgE that’s already attached itself to certain white blood cells, theoretically making it more effective. Previously, this was considered undruggable and Excellergy only recently dosed its first human patients. Poplar’s treatment, meanwhile, is described as an IgE “depleter,” which uses an undisclosed “triple-action mechanism” to hit free-flowing IgE, prevent it from binding to white blood cells, and reduce its production. Phase 1 data are expected in the second half of this year. Regeneron’s food allergy program is lagging behind its cat and birch allergy drugs, but it’s shooting for a combination approach with the megablockbuster Dupixent, which targets a different mechanism than IgE in a wide variety of conditions. Companies also see an opportunity for drugs more similar to Xolair that can be dosed less frequently. That’s the thesis behind GSK’s acquisition of RAPT, whose program ozureprubart is currently in a Phase 2b study. If everything works out, data could come next year with a possible launch in 2031. “The thing we liked about a Xolair-like product and a longer-acting version is the absolute convenience it provides,” GSK’s global business development chief Chris Sheldon said. Despite the excitement, there is no guarantee any of these approaches will succeed. Preventatively treating food allergy has remained a challenge among the few companies that have attempted it. Alladapt Immunotherapeutics shut down in 2024 after it couldn’t find the cash to run a Phase 3 study for an experimental food allergy drug, despite its earlier success. In January 2024, Novartis terminated a Phase 3 ligelizumab trial in peanut allergy because of dosing challenges, and the drug no longer appears on the company’s pipeline webpage. And Palforzia will soon be coming off the market for reasons unrelated to its safety or effectiveness. But the toughest hurdle could be the entrance of Xolair biosimilars, with one already approved and more expected this year. Xolair’s current annual list price is as high as $60,000 , and generics will likely be cheaper. A true Xolair competitor probably won’t reach the market until RAPT’s predicted 2031 launch. The Merida, Excellergy, Poplar and Regeneron food allergy drugs don’t yet have launch timelines. And due to the unusual timing of the biosimilar competition, the newer drugs will need to show substantial improvements in both convenience and effectiveness over Xolair to be widely used, said Heath Lukatch, co-founder of Red Tree Venture Capital, which seeded Excellergy. “In order to compete against those biosimilars with a brand new product, that’s just going to be the ticket to play,” Lukatch said.

AcquisitionPhase 3Drug ApprovalImmunotherapyClinical Result

31 Mar 2026

·www.pharmaceutical-technology.com

Teva receives FDA approval for Prolia biosimilar

The applications are supported by analytical and clinical data on safety, immunogenicity, and efficacy comparable to Xolair. Credit: SmartPhotoLab / Shutterstock.com. Teva Pharmaceutical has announced the US Food and Drug Administration (FDA) approval for Ponlimsi (denosumab-adet) as a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair (omalizumab) by both the agency and the European Medicines Agency (EMA). The FDA approval of Ponlimsi is based on a comprehensive evidence package, including analytical and clinical data showing immunogenicity, safety, and similar efficacy to Prolia. Ponlimsi is approved for all indications of the reference product, such as treating postmenopausal women with osteoporosis at high risk of fracture and increasing bone mass in men with osteoporosis. Additional indications include glucocorticoid-induced osteoporosis in men and women at high fracture risk, increasing bone mass in men undergoing androgen deprivation therapy for nonmetastatic prostate cancer, and in women undergoing adjuvant aromatase inhibitor therapy for breast cancer. The EMA granted marketing authorisation for Teva’s Ponlimsi in November 2025, following a positive opinion from the Committee for Medicinal Products for Human Use in the same year. Regulatory submissions for Teva’s proposed Xolair biosimilar include a biologics licence application to the FDA and a marketing authorisation application to the EMA in the European Union (EU). Both submissions cover all approved indications for Xolair: chronic spontaneous urticaria (ages 12 and above), chronic rhinosinusitis with nasal polyps (adults 18 and above), moderate-to-severe (US) / severe (EU) persistent allergic asthma (ages six and above), and, in the US, IgE-mediated food allergies (ages one and above). They are supported by analytical and clinical data on safety, immunogenicity, and efficacy comparable to Xolair. Teva biosimilars R&D head and chief science officer Steffen Nock said: “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. “With a strong early-stage pipeline and a suite of advancing programmes, we see significant potential to address patient needs and fuel Teva’s long-term growth.” In February 2025, Teva and Alvotech announced the US launch of the Selarsdi (ustekinumab-aekn) injection, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab).

Drug Approval

30 Mar 2026

·www.biospace.com

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 pro 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 . 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 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 . 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 . 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 . American Academy of Allergy, Asthma & Immunology (AAAAI). (n.d.). Sinusitis . American Academy of Allergy, Asthma & Immunology (AAAAI). (n.d.). Nasal Polyps . American Academy of Allergy, Asthma & Immunology (AAAAI). (n.d.). Hives (Urticaria) and Angioedema Overview . (urticaria)-and-angioedema-overview Children’s Hospital of Philadelphia. (2024). IgE-Mediated Food Allergies . . Teva Media Inquiries TevaCommunicationsNorthAmerica@tevapharm.com Teva Investor Relations Inquiries TevaIR@Tevapharm.com

Drug Approval

100 Deals associated with Omalizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D05251	Omalizumab	R03DX05	DB00043

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Food Hypersensitivity	United States	Genentech, Inc.	16 Feb 2024
Nasal Polyps	United States	Genentech, Inc.	30 Nov 2020
Rhinitis, Allergic, Seasonal	Japan	Novartis Pharmaceuticals KK	11 Dec 2019
Asthma	United States	Genentech, Inc.	20 Jun 2003
Allergic asthma	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002
Chronic rhinosinusitis with nasal polyps	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002
Chronic Urticaria	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic sinusitis	NDA/BLA	China	Beijing Novartis Pharma Co. Ltd.	19 Jul 2022
Chronic sinusitis	NDA/BLA	China	Novartis Europharm Ltd.	19 Jul 2022
Peanut Hypersensitivity	Phase 3	United States	Novartis Pharmaceuticals Corp.	22 Jul 2019
Peanut Hypersensitivity	Phase 3	United States	Genentech, Inc.	22 Jul 2019
Bronchitis	Phase 3	Canada	Novartis AG	01 Mar 2014
Angioedema	Phase 3	Germany	Novartis Pharmaceuticals Corp.	23 Jan 2013
Severe persistent asthma	Phase 3	France	Novartis Pharmaceuticals Corp.	01 Sep 2009
Seasonal allergic conjunctivitis	Phase 3	Germany	Novartis Pharmaceuticals Corp.	01 Feb 2006
Persistent asthma	Phase 3	-	Genentech, Inc.	01 Jul 2000
Hypersensitivity	Phase 2	United States	Genentech, Inc.	12 Feb 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03881696 (OUTMATCH, NEWS) Manual	Phase 3	Food Hypersensitivity	80	multi-food oral immunotherapy	iiiggfmijz(endjeequhb) = maungennuf axqaommjni (buonodnsrt ) View more	Positive	10 Feb 2026
				Omalizumab	iiiggfmijz(endjeequhb) = ggsiaqkfhj axqaommjni (buonodnsrt ) View more
NCT04998604 (EVEREST, CTgov)	Phase 4	Asthma \| Chronic rhinosinusitis with nasal polyps	360	Placebo+Dupilumab (Dupilumab 300 mg Q2W)	nzxypcchlf(rqaghwnkma) = gyjmybqhqa dhbrxjkwye (tohmthplrc, pohlzblaxl - xhqmtxqiks) View more	-	23 Oct 2025
				Placebo+Omalizumab (Omalizumab 75 to 600 mg Q2W/Q4W)	nzxypcchlf(rqaghwnkma) = wmaawuwghg dhbrxjkwye (tohmthplrc, orqmuczcgc - hidfgveurx) View more
NCT04998604 (EVEREST, Company_Website) Manual	Phase 4	Asthma \| Chronic rhinosinusitis with nasal polyps	360	Dupixent 300 mg every two weeks	lcapdjjpxy(pkkiuriaqz) = vpryzvoxqq wdouhitalc (emenrpfdxv ) View more	Positive	15 Jun 2025
				Xolair	-
AAD2025	Not Applicable	Chronic Urticaria	3,272	Omalizumab	ehhmpipwaq(tsoeqgzulm) = sgiouztlsn cbrewfjkey (rbclwobddj ) View more	Negative	07 Mar 2025
				systemic anti-inflammatories (SAI)	ehhmpipwaq(tsoeqgzulm) = dehfqrkhkd cbrewfjkey (rbclwobddj ) View more
OUtMATCH (PipelineReview) Manual	Phase 3	Food Hypersensitivity	-	Xolair (first head-to-head trial)	vhysgoklnb(ykgruroibf) = jknpmwpfyz hweyoevizp (kphoddqdqi )	Positive	03 Mar 2025
				OIT (first head-to-head trial)	vhysgoklnb(ykgruroibf) = swwmlvpirt hweyoevizp (kphoddqdqi )
ACAAI2024	Not Applicable	peanut-IgE \| peanut-SPT \| total-IgE	28	Peanut Oral Immunotherapy (POIT)	jbqjllhtlh(lfinjdekyy) = Mean QoL scores improved significantly from pre-OIT to M60 xfvnpsvdfr (aktzzuwnqs ) View more	Positive	24 Oct 2024
ACAAI2024	Not Applicable	Asthma	-	Mepolizumab	tealuuyxia(zsnslfciif) = stwvjredmr qwfqnvkhvz (xuattozyoz ) View more	-	24 Oct 2024
				Dupilumab	tealuuyxia(zsnslfciif) = kosfjvlptq qwfqnvkhvz (xuattozyoz ) View more
NCT06316414 (Pubmed \| Allergy)	Not Applicable	Severe asthma total IgE levels	65	Omalizumab	xokjeixsoy(qixndqxyli) = fybjcpfged lfacsdjkul (irubutdwzh ) View more	Positive	16 Sep 2024
				Placebo	xokjeixsoy(qixndqxyli) = qvzefselda lfacsdjkul (irubutdwzh ) View more
ERS2024	Not Applicable	Asthma	287	Allergen immunotherapy + ICS & LABA combination (mild)	jszebhfhop(cgnofxhnoj) = ugwrwwdgdn xtjselbgkh (kjptnnhiri )	Positive	07 Sep 2024
				Allergen immunotherapy + ICS & LABA combination (moderate)	jszebhfhop(cgnofxhnoj) = cxutqqzgtf xtjselbgkh (kjptnnhiri )
ERS2024	Not Applicable	Severe asthma	58	Omalizumab	emxewaxjpb(rlujvmsfmw) = rnlvmvspjp lnzjsxfwnj (pfpjhhlfpw ) View more	Positive	07 Sep 2024

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