Tel Aviv, Israel — November 25, 2025 — Leads & Copy — Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA), has received marketing authorizations from the European Commission (EC) for its two denosumab biosimilar candidates, PONLIMSI and DEGEVMA. The approvals, which follow positive opinions from the Committee for Medicinal Products for Human Use (CHMP) earlier in 2025, aim to broaden access to important bone health treatments across Europe.
PONLIMSI is a biosimilar to Prolia®, indicated for treating osteoporosis in postmenopausal women and men at increased risk of fractures. It is also for treating bone loss associated with hormone ablation in men with prostate cancer and bone loss in adults on long-term systemic glucocorticoid treatment. Available as a 60mg/1mL solution for injection in a pre-filled syringe, PONLIMSI contains denosumab, a human monoclonal IgG2 antibody that targets RANKL, a protein essential for osteoclast function, thereby reducing bone resorption.
DEGEVMA, a biosimilar to Xgeva®, is indicated for preventing bone complications in adults with advanced cancer involving bone and for treating adults and skeletally mature adolescents with giant cell tumor of bone. It will be available as a 120mg/1.7mL solution for injection in a vial. Like PONLIMSI, DEGEVMA also contains denosumab that targets RANKL.
Teva plans to launch both products in key European markets in the coming months. According to Steffen Nock, SVP Head of Biosimilars & Chief Science Officer, the approvals mark an important step in increasing patient access to biosimilar therapies for serious bone conditions. Michal Nitka, SVP Head Generics Europe & Global Head OTC, added that the launches underscore Teva’s commitment to providing treatment options for healthcare systems across Europe, especially where biosimilar access needs improvement.
The approvals mark a significant milestone in Teva’s biosimilars portfolio and align with Teva’s Pivot to Growth strategy, reinforcing the company’s commitment to broadening access to biosimilar medicines for patients.
Prolia® and Xgeva® are registered trademarks of Amgen, Inc.
Teva Media Inquiries: TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries: TevaIR@Tevapharm.com
Source: Teva Pharmaceutical Industries Ltd.
Source: Teva Pharmaceutical Industries Ltd.
