Denosumab

The European Commission (EC) has approved Biocon Biologics’ biosimilars referencing Amgen’s bone disease therapy denosumab. Biocon Biologics’ Vevzuo has been authorised to prevent bone complications in adults with advanced cancer involving the bone, and to treat adults and skeletally mature adolescents with giant cell tumour (GCT) of the bone. Meanwhile, the company’s Evfraxy has been approved to treat osteoporosis in men and postmenopausal women, as well as bone loss linked to hormone ablation in men with prostate cancer at an increased risk of fractures. The drug has also been approved to treat bone loss associated with long-term systemic glucocorticoid therapy in adults. A biosimilar, according to the European Medicines Agency (EMA), is a biological medicine that is highly similar to one already approved in the EU. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product. The EC’s decision on Vevzuo and Evfraxy follows a recent recommendation from the EMA’s human medicines committee and was supported by clinical data showing that both biosimilars have comparable quality, safety and efficacy to the reference product. An estimated 32 million people aged 50 years and over in Europe were living with osteoporosis in 2019. The disease, which disproportionately impacts women, weakens bones and makes them more likely to break. Additionally, almost all types of cancer can spread to the bone and cause pain and fractures, while GCTs, benign tumours that typically occur in young adults, can grow quickly and destroy surrounding bone and soft tissue. Denosumab is a human monoclonal antibody that is designed to increase bone mass and strength by blocking the action of the RANKL protein, which plays a critical role in the formation, function and survival of osteoclasts. Biocon Biologics’ chief executive officer and managing director, Shreehas Tambe, said: “These denosumab biosimilars mark another significant milestone in our rapid expansion, and support for healthcare systems in the region.” The authorisation comes less than five months after the EC approved Biocon Biologics’ Yesintek, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat multiple inflammatory diseases.

JERSEY CITY, NJ, USA I July 7, 2025 I Celltrion USA today announced that STOBOCLO ® (denosumab-bmwo) and OSENVELT ® (denosumab-bmwo), biosimilars referencing PROLIA ® (denosumab) and XGEVA ® (denosumab) respectively, are commercially available in the United States. STOBOCLO is available in 60 mg/mL injection and is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. [1] OSENVELT is available in 120 mg/1.7 mL (70 mg/mL) injection and is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. [2] “We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and healthcare professionals a valuable alternative treatment option. Building on our strong heritage in biosimilars, Celltrion remains committed to being a trusted partner for both patients and physicians, while contributing to the overall sustainability of healthcare systems.” STOBOCLO and OSENVELT are supported by Celltrion’s comprehensive patient support programs designed to help empower patients to navigate their treatment journeys. Celltrion offers a suite of resources, including the Celltrion CONNECT ® Patient Support Program and the Celltrion CARES™ Co-pay Assistance Program. Patients who are uninsured may be able to receive STOBOCLO and OSENVELT at no cost. Visit www.CelltrionConnect.com and www.CelltrionCares.com to learn more. Celltrion’s biosimilars portfolio covers the areas of immunology, oncology, gastroenterology, allergy, and endocrinology. About STOBOCLO ® (denosumab-bmwo) STOBOCLO ® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA ® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. INDICATIONS STOBOCLO ® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment: For more information, see Full Prescribing Information . About OSENVELT ® (denosumab-bmwo) OSENVELT ® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA ® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. INDICATION OSENVELT ® (denosumab-bmwo) is indicated for: For more information, see Full Prescribing Information . About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-u s and stay updated with our latest news and events on our social media – LinkedIn , Instagram , X , and Facebook . About Celltrion USA Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion’s FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd), YUFLYMA ® (adalimumab-aaty), AVTOZMA ® (tocilizumab-anho), STEQEYMA ® (Ustekinumab-stba) STOBOCLO ® (denosumab-bmwo), OSENVELT ® (denosumab-bmwo), and OMLYCLO ® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media – LinkedIn . [1] STOBOCLO U.S. prescribing information (2025) [2] OSENVELT U.S. prescribing information (2025) US-CT-P41-25-00006 SOURCE: Celltrion