European Commission Approves Henlius and Organon’s Denosumab Biosimilars BILDYOS® and BILPREVDA® for All Indications of Reference Medicines
The European Commission (EC) has granted marketing authorization to Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) for two denosumab biosimilars, BILDYOS® (denosumab) injection 60 mg/mL and BILPREVDA® (denosumab) injection 120 mg/1.7 mL. These products are approved as biosimilars to PROLIA® and XGEVA®, respectively, covering all indications of the reference medicines across the European Union (EU).
The approvals mark an important step in expanding patient access to vital bone health therapies, especially for women who are disproportionately impacted by osteoporosis and other conditions associated with bone fragility. With these authorizations, Henlius and Organon now have the regulatory green light to commercialize their biosimilar products across Europe, adding to earlier approvals obtained in the United States.
Significance of the Approval
Denosumab, a monoclonal antibody targeting RANKL (receptor activator of nuclear factor kappa-B ligand), has become an essential treatment for multiple bone-related conditions. Its branded versions, Amgen’s Prolia® and Xgeva®, have generated billions in annual sales globally. Prolia is widely prescribed for osteoporosis in postmenopausal women and men at high risk of fractures, while Xgeva is primarily used to prevent skeletal-related events in patients with advanced malignancies involving bone.
By approving Henlius and Organon’s biosimilars, the EC has opened the door to more affordable treatment options for European patients. Biosimilars, which are highly similar to already approved biological medicines, have been shown to deliver comparable efficacy and safety while offering the potential to reduce healthcare costs. This is especially critical in Europe, where aging populations and rising healthcare expenditures are increasing pressure on public health systems.
Nico Van Hoecke, Head of International Commercial at Organon, emphasized the milestone nature of these approvals:
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. 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. 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 healthcare systems.
Product Profiles and Indications
BILDYOS® (Denosumab, biosimilar to Prolia®)
BILDYOS has been authorized for the same set of indications as Prolia, including:
- Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.
- Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
- Treatment of bone loss due to long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
Osteoporosis, a chronic condition characterized by low bone mass and deterioration of bone tissue, affects millions of Europeans. Women, particularly after menopause, face a heightened risk due to hormonal changes. The availability of a biosimilar alternative like BILDYOS could significantly improve treatment accessibility and adherence.
BILPREVDA® (Denosumab, biosimilar to Xgeva®)
BILPREVDA mirrors the clinical applications of Xgeva and has been approved for:
- Prevention of skeletal-related events (such as fractures or spinal cord compression) in adults with advanced malignancies involving bone.
- Treatment of giant cell tumour of bone in adults and skeletally mature adolescents when surgery is not feasible or would cause severe morbidity.
Bone complications remain a common challenge in cancer care, especially for patients with metastatic disease. Xgeva has been a critical option in reducing skeletal complications and improving quality of life. BILPREVDA’s entry into the European market offers oncologists and patients an equally effective, more accessible alternative.
Regulatory Review and Clinical Data
The EC’s approval followed a rigorous review of a comprehensive data package, which included:
- Analytical studies comparing the structural and functional properties of the biosimilars to the reference products.
- Pharmacokinetic studies to demonstrate similarity in drug metabolism and distribution.
- Comparative clinical trials confirming equivalence in efficacy, safety, and immunogenicity between the biosimilars and their reference products.
The data confirmed that BILDYOS and BILPREVDA are highly similar to Prolia and Xgeva, with no clinically meaningful differences in safety or effectiveness. Importantly, the immunogenicity profile—an essential consideration for biologics—was comparable to the reference drugs.
Dr. Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, highlighted the collaborative achievement:
These approvals are a testament to the strong collaboration between Henlius and Organon aimed at meeting the needs of both patients and the healthcare system in Europe. 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.
Strategic Collaboration Between Henlius and Organon
The approvals are also the result of a strong commercial partnership between the two companies. In 2022, Henlius signed a license and supply agreement with Organon, granting the latter exclusive global commercialization rights—outside of China—for multiple biosimilars, including BILDYOS and BILPREVDA.
Henlius, a China-based biopharmaceutical company, has built a robust pipeline of biosimilars and innovative biologics. Its focus on cost-effective therapies has positioned it as a rising player in the global biosimilars market. Organon, a global women’s health company spun out of Merck in 2021, brings extensive commercialization expertise and an established footprint in key international markets, making the partnership strategically well-aligned.
Implications for Patients and Healthcare Systems
The arrival of biosimilars like BILDYOS and BILPREVDA in Europe could have a transformative impact:
- Expanded Access: Lower-cost alternatives can help ensure more patients receive treatment, particularly in regions where affordability is a barrier.
- Healthcare Savings: Biosimilars typically reduce treatment costs, easing the financial burden on public health systems.
- Therapeutic Choice: Physicians gain more options for tailoring therapy to patient needs, supporting individualized treatment plans.
- Sustainability: Widespread biosimilar adoption contributes to more sustainable healthcare systems by redistributing resources to other areas of need.
Europe has historically been at the forefront of biosimilar adoption, with regulatory frameworks designed to encourage competition while maintaining rigorous safety and efficacy standards. The approval of Henlius and Organon’s products further reinforces Europe’s leadership role in this sector.
