Organon and Henlius Bilprevda Approved in Europe to Target Xgeva Market
Regulatory Clearance for EU-Wide Sales
The European Commission (EC) approved Bilprevda (denosumab) by Organon (OGN) and Shanghai Henlius Biotech (2696.HK) on September 17, 2025. This marks the final marketing authorization following the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on July 24, 2025, with the status now set as Approval/Marketed. Bilprevda, a 120mg/1.7mL injection, is a biosimilar referencing Amgen’s (AMGN) Xgeva (denosumab) and is now positioned to proceed with country-specific pricing and reimbursement negotiations across all EU member states.
RANKL Inhibition to Prevent Skeletal Complications in Cancer Patients
Denosumab is a human monoclonal antibody that inhibits receptor activator of nuclear factor kappa-B ligand (RANKL), essential for osteoclast formation, function, and survival. The approved indications include the prevention of skeletal-related events (SREs) such as pathological fractures, radiation therapy, spinal cord compression, and bone surgery in adults with bone-invasive progressive malignant tumors, as well as the treatment of giant cell tumor of bone in adults and skeletally mature adolescents who are not candidates for surgery or face high surgical complication risks. Current standard therapies include Xgeva and intravenous bisphosphonates like zoledronic acid. Biosimilars do not introduce new mechanisms but compete on cost based on high similarity in quality, pharmacokinetics, efficacy, and safety.
Commercialization of a 541 Million Dollar Agreement
Organon secured exclusive commercialization rights outside China for HLX14 denosumab and HLX11 pertuzumab biosimilars in 2022, while Henlius is responsible for development, manufacturing, and supply. The total contract value for both assets is up to 541 million dollars, including an upfront payment of 73 million dollars and potential development, regulatory, and commercial milestones of up to 468 million dollars. In 2022, 27 million dollars in development milestones were paid, and the EU approval of Bilprevda signifies the transition of the technology transfer value from clinical development to country-specific launch and tender competition stages.
Pre-Existing Multi-Party Price Competition
Sandoz’s (SDZ) Wyost, the first Xgeva biosimilar in Europe, was approved on May 17, 2024, followed by Vevzuo by Biocon Biologics and Viatris on June 25, 2025, and Bomyntra by Fresenius Kabi on July 17, 2025. Therefore, Bilprevda must now compete with established products in hospital tender and distribution channels, where discount rates and supply stability, rather than approval itself, will determine market share. Xgeva’s 2025 global sales were 2.084 billion dollars, a 6% decline year-over-year, with Amgen also acknowledging revenue erosion from biosimilar launches, indicating market transition is already reflected in numbers.
The EU approval of Bilprevda marks Organon and Henlius’ transition of their two-asset contract, valued up to 541 million dollars, into the approval and commercialization phase. The reference product, Xgeva, recorded 2.084 billion dollars in 2025 sales, but a 6% decline was observed due to biosimilar impact, confirming both substitution demand and pricing pressure. Immediate competitors include Sandoz’s Wyost, Viatris and Biocon’s Vevzuo, and Fresenius Kabi’s Bomyntra, with country-specific tender pricing and supply capabilities determining market share. In the medium to long term, the expansion of RANKL biosimilars will enhance access to skeletal complication prevention in cancer patients, while eroding Amgen’s brand revenue and accelerating Organon’s biosimilar portfolio monetization.
Source: EMA (ema)