On November 24, 2025, Alvotech announced that the European Commission (EC) has approved AVT03 as a biosimilar to Amgen’s PROLIA® and XGEVA® (denosumab) in the European Economic Area. AVT03 is approved in two presentations: as a biosimilar to PROLIA® 60 mg/1 mL in a single-use pre-filled syringe for the treatment of osteoporosis and bone loss, and as a biosimilar to XGEVA® 120 mg/1.7 mL (70 mg/mL) in a single-use vial for the prevention of skeletal-related events in adults with advanced malignancies involving bone. Alvotech notes that the EC’s decision was based on a “totality of evidence,” which included comparative analytical, pharmacokinetic, and pharmacodynamic data, as well as clinical data from two studies using PROLIA® as the reference product. The results demonstrated equivalent pharmacokinetics and efficacy, along with comparable safety and immunogenicity to the reference product.
In Europe, AVT03 will be commercialized through partnerships with STADA and Dr. Reddy’s, each holding semi‑exclusive rights in the EEA, Switzerland, and the UK. STADA will market AVT03 as KEFDENSIS® (biosimilar to PROLIA®) and ZVOGRA® (biosimilar to XGEVA®), while Dr. Reddy’s will market the products as ACVYBRA® (biosimilar to PROLIA®) and XBONZY® (biosimilar to XGEVA®).
Additionally, on November 25, 2025, Teva Pharmaceuticals International GmbH announced that the EC has granted marketing authorizations for its two denosumab biosimilars PONLIMSI® and DEGEVMA®. PONLIMSI is a PROLIA® biosimilar indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, as well as bone loss associated with hormone ablation therapy in men with prostate cancer and in adults receiving long-term systemic glucocorticoid therapy. DEGEVMA is a XGEVA® biosimilar 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. Teva reports that PONLIMSI will be available as a 60 mg/1 mL solution for injection in a pre‑filled syringe, while DEGEVMA will be available as a 120 mg/1.7 mL solution for injection in a vial. In both cases, Teva states that comprehensive analytical, preclinical, and clinical data demonstrate comparable quality, safety, and efficacy to the respective reference products PROLIA® and XGEVA®. Teva plans to launch both products in key European markets “in the coming months” as part of its broader “Pivot to Growth” biosimilars strategy.