Shanghai Henlius Biotech, Inc., and Organon  announced the European Commission (EC) has granted marketing authorization for BILDYOS^® (denosumab) injection 60 mg/mL and BILPREVDA^® (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.

"The EC approvals of BILDYOS and BILPREVDA mark a pivotal moment in expanding access to essential bone care treatments for millions of Europeans, particularly women, who are disproportionately affected by osteoporosis," said Nico Van Hoecke, Head, International Commercial at Organon. "These biosimilars may offer additional treatment options across several therapeutic areas associated with bone loss, including osteoporosis, and reflect Organon's commitment to advancing women's health through access to important medicines.^[4] These approvals, following those in the United States, not only expand the global reach of these biosimilars but also support the sustainability of Europe's health care systems."

"These approvals are a testament to the strong collaboration between Henlius and Organon aimed at meeting the needs of both patients and the health care system in Europe," said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. "Through our commitment to scientific excellence and product quality, we're building on approvals in the United States to bring these biosimilar treatment options to people who need them around the world."

BILDYOS is indicated for treatment of osteoporosis in postmenopausal women and in men at increased risk for fracture, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. BILPREVDA is indicated for the prevention of skeletal related events in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

BILDYOS and BILPREVDA were approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and a comparative clinical study demonstrating that BILDYOS and BILPREVDA are each a biological medicine highly similar to another biological medicine already approved in the EU (called 'reference medicine') in terms of structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response).

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS and BILPREVDA. The agreement covers exclusive global commercialization rights except for China.