Just in December, six companies have announced the launch of their denosumab biosimilars in Europe: Sandoz, Samsung Bioepis, Fresenius Kabi, Zentiva, Biocon Biologics, and Accord.
On December 1, 2025:
- Sandoz launched its denosumab biosimilars, WYOST (120 mg) and JUBBONTI (60 mg) in Europe. WYOST is approved for the treatment of cancer-related bone disease, referencing Amgen’s XGEVA, and JUBBONTI is approved to treat osteoporosis, referencing Amgen’s PROLIA. Sandoz anticipates additional rollouts of the medicine throughout 2026. This launch builds on Sandoz’s launch of WYOST and JUBBONTI in the U.S. earlier this year. As we previously reported, the European Commission granted marketing authorization for both biosimilars on May 22, 2024.
- Samsung Bioepis announced the launch of its denosumab biosimilars in Europe. OBODENCE (60 mg pre-filled syringe), referencing Amgen’s PROLIA, is approved for the treatment of osteoporosis, and XBRYK (120 mg vial), referencing Amgen’s XGEVA, is approved for the prevention of fractures and other skeletal events occurring in patients with cancer. OBODENCE will be available in December 2025 and XBRYK will be available in January 2026. As we previously reported, the European Commission granted marketing authorization for both biosimilars on February 16, 2025.
- Fresenius Kabi announced the European launch of its denosumab biosimilars CONEXXENCE and BOMYNTRA. CONEXXENCE (60 mg), referencing Amgen’s PROLIA, is approved for the treatment of osteoporosis in postmenopausal women and men at increased risk of fracture and for bone loss associated with hormone ablation in cancer patients. BOMYNTRA (120 mg), referencing Amgen’s XGEVA, is approved for the prevention of skeletal-related events in adults with advanced malignancies involving bone and for the treatment of giant cell bone tumors. Both biosimilars received marketing authorization from the European Commission in July 2025.
- Zentiva announced the first EU-wide launch of its denosumab biosimilar ZADENVI. ZADENVI (60 mg), referencing PROLIA, is approved for the treatment of osteoporosis and for bone loss in certain patients. Zentiva received marketing authorization from the European Commission in June 2025.
On December 2, 2025:
- Biocon Biologics announced the market entry of its denosumab biosimilars, EVFRAXY® and VEVZUO®, which reference PROLIA and XGEVA, as part of a settlement agreement with Amgen. Marketing authorization was granted by the European Commission on July 3, 2025.
- Accord Healthcare announced the launch of its denosumab biosimilars OSVYRTI (60 mg pre-filled syringe), referencing PROLIA, and JUBEREQ (120 mg vial), referencing XGEVA following the expiry of three patents on November 27, 2025. OSVYRTI is indicated for the treatment of osteoporosis and bone loss. JUBEREQ is indicated for the prevention of skeletal related events in patients with cancer. As we previously reported, Accord announced both biosimilars received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) on April 2, 2025.
In addition to the denosumab launches, Samsung Bioepis announced on December 2 that its ranibizumab biosimilar, BYOOVIZ® pre-filled syringe (PFS), which references Genetech’s Lucentis, received a positive opinion from the EMA’s CHMP. As we previously reported, the EMA’s CHMP first adopted a positive opinion for BYOOVIZ® as a single use vial for intravitreal use (0.5 mg/0.05 mL) on June 25, 2021, which was followed by market approval by the European Commission in August 2021. It is approved to treat several conditions: neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch or central) and visual impairment due to choroidal neovascularization. Commercialization in Europe of the single use vial is expected to begin in January 2026, followed by the PFS presentation in second quarter 2026.
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