Teva receives European Commission approvals for PONLIMSI® (denosumab) Biosimilar to Prolia® and DEGEVMA® (denosumab) Biosimilar to Xgeva®
Rhea-AI Summary
Teva (NYSE: TEVA) announced that the European Commission granted marketing authorizations on Nov 25, 2025 for two denosumab biosimilars: PONLIMSI (biosimilar to Prolia) and DEGEVMA (biosimilar to Xgeva).
The approvals follow positive CHMP opinions and allow Teva to launch both products in key European markets in the coming months. Teva frames the authorizations as a milestone for its biosimilars portfolio and part of its Pivot to Growth strategy to broaden patient access to bone‑health biologics across Europe.
Positive
- European Commission marketing authorizations granted on Nov 25, 2025
- PONLIMSI approved as a biosimilar to Prolia
- DEGEVMA approved as a biosimilar to Xgeva
- Company plans to launch both products in key European markets in the coming months
- Approvals cited as reinforcing Teva's biosimilars portfolio and Pivot to Growth strategy
Negative
- None.
Insights
European approvals for two denosumab biosimilars should expand treatment options and support Teva's biosimilars growth push.
Teva now holds European marketing authorisations for PONLIMSI (biosimilar to Prolia) and DEGEVMA (biosimilar to Xgeva), enabling product launches in key European markets in the coming months. This converts regulatory clearance into a near-term commercial opportunity: authorised products can be introduced to hospitals, specialty clinics, and national procurement processes where denosumab is used for bone conditions.
Commercial upside depends on rollout speed, tender outcomes, and payor acceptance; these approvals remove the main regulatory barrier but do not by themselves guarantee uptake. Watch national reimbursement decisions and hospital formulary inclusions over the next 3–12 months as the primary near-term signals of revenue contribution.
CHMP-positive opinions culminated in EC marketing approvals, solidifying regulatory standing for two denosumab biosimilars across the EU.
The European Commission granted marketing authorisations for PONLIMSI and DEGEVMA following CHMP positive opinions earlier in the year, which confirms the products meet EU safety, efficacy, and quality standards for biosimilars. This authorisation centralises regulatory clearance for all EU member states and removes national-level market-entry uncertainty tied to approval.
Implementation risks include country-specific pricing and reimbursement timelines and any local procedural steps before product supply begins. Monitor national reimbursement approvals and announced launch schedules in major EU markets over the coming months to assess how quickly patients will gain access.
- Following the positive opinions of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorizations for Teva’s biosimilars PONLIMSI and DEGEVMA expanding access to important bone health treatments across Europe
- These approvals mark another significant milestone in Teva’s strong biosimilars portfolio, in line with Teva's Pivot to Growth Strategy
- The approvals underscore Teva’s commitment to broadening access to biosimilars
TEL AVIV, Israel, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) announced that the European Commission (EC) has granted marketing authorizations for its two denosumab biosimilar candidates – PONLIMSI, a biosimilar to Prolia®1 and DEGEVMA, a biosimilar to Xgeva®, following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) earlier this year.
These approvals mark another significant milestone in Teva’s industry-leading biosimilars portfolio and its ongoing commitment to improving patient access to essential biologic therapies across Europe. Teva plans to launch both products in key European markets in the coming months.
The approval represents an important step in advancing Teva’s Pivot to Growth strategy, reinforcing the company’s dedication to broadening access to biosimilar medicines for patients.
Steffen Nock, SVP Head of Biosimilars & Chief Science Officer, said: “This approval represents an important step forward in increasing patient access to biosimilar therapies for serious bone conditions, underscoring our commitment to supporting better care for patients."
Michal Nitka, SVP Head Generics Europe & Global Head OTC, added: "Through product launches like these, we remain committed to providing additional treatment options for healthcare systems across Europe – especially in countries where access to biosimilars can still be improved."
About PONLIMSI
PONLIMSI (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and men who are at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer who are at increased risk of fractures or treatment of bone loss in adults who are on long-term treatment with systemic glucocorticoid.
The active substance, denosumab, is a human monoclonal IgG2 antibody that targets the protein RANKL, essential for the formation, function, and survival of osteoclasts - the cells responsible for bone resorption. By binding to RANKL with high affinity and specificity, denosumab prevents the interaction between RANKL and RANK, leading to a decrease in bone resorption in cortical and trabecular bone.
PONLIMSI will be available as a 60mg/1mL solution for injection in a pre-filled syringe.
PONLIMSI is a biosimilar medicinal product, similar to the reference medicine Prolia® (denosumab), which was authorized in the EU on May 26, 2010.
Comprehensive analytical, preclinical, and clinical data demonstrate that PONLIMSI has comparable quality, safety, and efficacy to the reference product.
About DEGEVMA
DEGEVMA (denosumab) is indicated for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone.
The active substance, denosumab, is a human monoclonal IgG2 antibody that targets the protein RANKL, essential for the formation, function, and survival of osteoclasts - the cells responsible for bone resorption. By binding to RANKL with high affinity and specificity, denosumab prevents the interaction between RANKL and RANK, leading to a decrease in bone resorption in cortical and trabecular bone.
DEGEVMA will be available as a 120mg/1.7mL solution for injection in a vial.
DEGEVMA is a biosimilar medicinal product, similar to the reference product Xgeva® (denosumab), which was authorized in the EU on July 13, 2011.
Comprehensive analytical, preclinical, and clinical data demonstrate that DEGEVMA has comparable quality, safety, and efficacy to the reference product.
About Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is 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.
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 develop and commercialize PONLIMSI (denosumab) for the treatment and prevention of osteoporosis in postmenopausal women and men at increased risk of fractures; our ability to successfully develop and commercialize DEGEVMA (denosumab) for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone; 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 other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward Looking Statements.” 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.
Teva Media Inquiries
TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries
TevaIR@Tevapharm.com
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1 Prolia® and Xgeva® are registered trademarks of Amgen, Inc.
FAQ
What did Teva announce about PONLIMSI and DEGEVMA on Nov 25, 2025?
When will Teva launch PONLIMSI and DEGEVMA in European markets (TEVA)?
What conditions do PONLIMSI (TEVA) and DEGEVMA approvals cover in Europe?
How do the EC approvals fit into Teva's strategy (TEVA)?
Did the approvals follow any regulatory committee recommendation for TEVA?
