SHANGHAI, China & JERSEY CITY, NJ – September 19, 2025, Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the European Commission (EC) has granted marketing authorization for BILDYOS® (denosumab) 60 mg/mL and BILPREVDA® (denosumab) 120 mg/1.7 mL, biosimilars to PROLIA® and XGEVA®, respectively. These approvals cover all indications of the reference products, marking a significant expansion of treatment options for patients across Europe.
Science Significance
BILDYOS and BILPREVDA are RANK ligand (RANKL) inhibitors that target bone loss across multiple conditions, including postmenopausal osteoporosis, hormone therapy–related bone loss, glucocorticoid-induced osteoporosis, and skeletal-related complications from cancers. The approvals were based on comprehensive analytical, pharmacokinetic, and comparative clinical data demonstrating these biosimilars are highly similar to the reference biologics in terms of structure, activity, efficacy, safety, and immunogenicity.
The EC approvals also underscore the potential of biosimilars to provide scientifically validated, cost-effective alternatives to originator biologics, supporting a broader understanding of therapeutic equivalence and reinforcing confidence in biosimilar development standards.
Regulatory Significance
The European Commission’s decision follows prior U.S. approvals and reflects rigorous compliance with EU regulatory frameworks for biosimilar medicines. BILDYOS is indicated in Europe for osteoporosis treatment in postmenopausal women and men at increased risk of fracture, as well as bone loss associated with hormone ablation therapy and long-term glucocorticoid use. BILPREVDA is approved for prevention of skeletal-related events in advanced malignancies and treatment of giant cell tumor of bone.
Advertisement
This milestone reinforces the harmonization of global regulatory standards for biosimilars and sets a precedent for efficient, science-based approvals that balance patient safety with timely access.
Business Significance
Henlius and Organon’s partnership, initiated in 2022 through a license and supply agreement, grants Organon exclusive commercialization rights outside of China, enabling rapid market entry and global scaling of these biosimilars. Organon’s Head of International Commercial Nico Van Hoecke emphasized that these approvals expand the global reach of the biosimilars and support the sustainability of European healthcare systems.
For Henlius, these approvals demonstrate the company’s successful integration of R&D, manufacturing, and commercialization capabilities, and strengthen its position in the competitive biopharmaceutical market. The collaboration exemplifies how strategic licensing and cross-border partnerships can accelerate access to high-quality biosimilars worldwide.
Patients’ Significance
Millions of European patients, especially women disproportionately affected by osteoporosis, stand to benefit from these approvals. BILDYOS and BILPREVDA provide additional, clinically validated options for managing bone loss and preventing fractures. These treatments also address gaps in care for patients undergoing hormone therapies, glucocorticoid treatment, or cancer-related bone complications, offering potential improvements in quality of life and long-term outcomes.
Patient safety remains paramount. Both products carry warnings including hypocalcemia, osteonecrosis of the jaw, atypical femoral fractures, and risks following treatment discontinuation. Clinicians are advised to monitor calcium levels, oral health, and fracture risk, ensuring personalized, safe administration of these biosimilars.
Policy Significance
By providing high-quality, cost-effective alternatives to originator biologics, these approvals support healthcare sustainability and accessibility in Europe. Biosimilars like BILDYOS and BILPREVDA reduce treatment costs, promote competition, and improve patient access to essential therapies. Regulators, policymakers, and healthcare systems can leverage these approvals to enhance coverage and reimbursement policies for osteoporosis and cancer-related bone treatments, advancing public health objectives.
The approvals also signal the EU’s commitment to science-based regulatory pathways that encourage innovation while ensuring safety, a model that could inform policy frameworks in other global regions.
Transaction Highlights
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon exclusive commercialization rights for BILDYOS, BILPREVDA, and other selected biosimilars outside of China. This strategic collaboration enables rapid market entry and global distribution, leveraging Henlius’ expertise in biopharmaceutical development and manufacturing alongside Organon’s commercial capabilities. The European Commission approvals represent the first major regulatory milestone under this partnership in Europe, following prior U.S. authorizations. By combining the strengths of both companies, the agreement aims to expand patient access to high-quality biosimilars, optimize global supply chains, and strengthen competitive positioning in the biosimilar market.
Source: Jorgan on & Henlius Press Release
