Teva Intensifies Biosimilar Competition with FDA Approval and Dual Filing Acceptance in US and Europe

With biosimilar competition now targeting high-value immunology biologics, Teva Pharmaceutical Industries has achieved several milestones with the FDA approval of denosumab-adet (brand name Ponlimsi), its biosimilar product referencing denosumab (brand name Prolia from Amgen), and the dual acceptances by FDA and the European Medicines Agency of regulatory filings for a biosimilar candidate referencing omalizumab (brand name Xolair from Novartis and Genentech).¹

Announced in late March 2026,¹ these developments underscore growing industry pressure to introduce lower-cost alternatives in markets historically dominated by originator biologics. Denosumab-adet is approved for all indications for which Prolia is approved, according to the company. These indications 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.¹

The company’s investigational omalizumab biosimilar candidate is designed to bind to immunoglobulin E (IgE), a key driver of allergic responses, and prevent activation of immune cells responsible for inflammation and hypersensitivity reactions. By interrupting this pathway, the biosimilar candidate aims to reduce symptom severity and potentially prevent allergic reactions before they occur. The product remains in development and has not yet received regulatory approval in any market, according to the company.

How do biosimilars to omalizumab expand access in allergic diseases?

Omalizumab has become a foundational biologic in the treatment of several IgE-mediated conditions, particularly allergic asthma. As the most common form of asthma, allergic asthma is characterized by airway inflammation triggered by environmental allergens, leading to symptoms such as wheezing, coughing, shortness of breath, and chest tightness. While biologics like omalizumab have significantly improved disease control for many patients, their high cost has limited access in some healthcare systems.²

Beyond asthma, omalizumab is also used in other chronic inflammatory conditions where IgE plays a central role. Teva’s biosimilar candidate is being positioned to potentially address these broader indications, aligning with strategies to maximize clinical and commercial reach across multiple disease areas.

What role does IgE targeting play across multiple chronic conditions?

IgE-mediated mechanisms are implicated in a range of chronic diseases beyond asthma. Chronic rhinosinusitis with nasal polyps, for example, is a long-term inflammatory condition affecting the nasal passages and sinuses. The presence of nasal polyps can obstruct airflow and significantly impair quality of life, with symptoms often persisting for 12 weeks or longer.³

IgE is also central to food allergies, where exposure to specific allergens such as milk, eggs, wheat, or nuts can trigger rapid and sometimes severe immune responses. While avoidance remains the primary management strategy, accidental exposure continues to pose significant risks, underscoring the need for additional therapeutic options.¹

How could biosimilars reshape competition in immunology biologics?

The development of biosimilars to established biologics like omalizumab reflects a broader shift toward lifecycle competition in immunology. As patents expire, biosimilar entrants are expected to drive pricing pressure while maintaining comparable clinical performance, creating new dynamics for both originator companies and healthcare providers.⁴

As regulatory pathways for biosimilars continue to mature globally, the introduction of IgE-targeting alternatives could play a critical role in improving access to biologic therapies. If approved, Teva’s candidate may contribute to a more competitive and accessible treatment landscape across allergic and immunologic diseases, where unmet need and healthcare costs remain significant challenges.¹

References

1. Teva Pharmaceutical Industries. Teva gains biosimilar momentum with US FDA approval of PONLIMSI (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab). Published March 30, 2026. Accessed April 1, 2026. https://www.tevapharm.com/news-and-media/latest-news/teva-gains-biosimilar-momentum-with-u.s.-fda-approval-of-ponlimsi-denosumab-adet-and-dual-filing-accep
2. Wu AC, Paltiel AD, Kuntz KM, Weiss ST, Fuhlbrigge AL. Cost-effectiveness of omalizumab in adults with severe asthma: results from the Asthma Policy Model. J. Allergy Clin. Immunol. 2007;120(5):1146-1152. doi: 10.1016/j.jaci.2007.07.055
3. Kariyawasam HH, James LK. Chronic rhinosinusitis with nasal polyps: Targeting IgE with anti-IgE omalizumab therapy. Drug Des Devel Ther. 2020;14:5483-5494. doi: 10.2147/DDDT.S226575
4. Jang M, Lee J, Yi S, Kwon TS. Budget impact of introducing an omalizumab biosimilar in 23 European countries. J Med Econ. 2025;28(1):1639-1650. doi: 10.1080/13696998.2025.2558450