Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., has received marketing authorizations from the European Commission for its two denosumab biosimilars—Ponlimsi, referencing Prolia, and Degevma, referencing Xgeva. The approvals follow a positive opinion from the EMA’s Committee for Medicinal Products for Human Use earlier this year.

The decision marks a key milestone in Teva’s expanding biosimilars portfolio and strengthens its efforts to improve access to biologic therapies across Europe. The company plans to launch both medicines in major European markets in the coming months, supporting its Pivot to Growth strategy.

“These approvals represent an important step forward in increasing patient access to biosimilar therapies for serious bone conditions,” said Steffen Nock, SVP, Head of Biosimilars & Chief Science Officer. Michal Nitka, SVP, Head Generics Europe & Global Head OTC, added that the launches will offer additional treatment options in regions where biosimilar access remains limited.

Ponlimsi (60 mg/1 mL, pre-filled syringe) is indicated for osteoporosis and bone loss associated with hormone ablation or long-term glucocorticoid therapy. Degevma (120 mg/1.7 mL vial) is indicated for preventing bone complications in adults with advanced cancer involving bone and for treating giant cell tumour of bone in adults and skeletally mature adolescents.

Both products have demonstrated comparable quality, safety, and efficacy to their reference medicines through comprehensive analytical, preclinical, and clinical studies.