European EMA Approves Henlius and Organon's Denosumab Biosimilar, Bildyos
European Approval for Denosumab Biosimilar, Bildyos
The European Medicines Agency (EMA) has granted final approval for Bildyos, a denosumab biosimilar co-developed by Shanghai Henlius Biotech (2696) and Organon (OGN). This approval marks a significant shift in the European market for bone health treatments, which was previously dominated by Amgen's (AMGN) original drug, Prolia. Bildyos is a monoclonal antibody that targets RANKL (Receptor Activator of Nuclear Factor kappa-B Ligand), a protein that regulates the survival and activity of osteoclasts. With this approval, a more affordable treatment option for osteoporosis patients will be widely available across the European Union (EU).
Proven Clinical Equivalence and Safety Compared to the Original
The European approval of Bildyos is based on data from a large, global Phase 3 clinical trial (NCT05352516) that demonstrated high similarity to the original drug, Prolia. In a clinical trial involving postmenopausal women with osteoporosis, the mean change in lumbar spine bone mineral density (BMD) at week 52 was 6.10% for the Bildyos group and 5.90% for the Prolia group. The adjusted mean difference between the two groups was 0.23%, which falls within the pre-defined equivalence range of -1.45% to 1.45%. No clinically significant differences were observed in terms of pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity, meeting the stringent review criteria of regulatory authorities.
Fierce Competition for Market Share in the $4.4 Billion Osteoporosis Market
The annual global sales of the original drug, Prolia, are approximately $4.414 billion in 2025, with the European market accounting for a significant portion. The entry of Bildyos into the market, along with other competing biosimilars such as Jubbonti from Sandoz, is expected to disrupt the original drug's monopoly. Amgen has already experienced a sharp decline in sales of its Prolia and Xgeva product lines, with a 32% decrease in global sales in the first quarter of 2026, reflecting the impact of biosimilar launches. With Organon's strong distribution network and marketing capabilities in Europe, Bildyos is expected to rapidly gain market share upon launch.
Henlius and Organon's Joint Efforts and Financial Performance
The successful European approval of Bildyos is the result of a close strategic partnership between Henlius, the developer, and Organon, which holds global commercial rights. In June 2022, the two companies signed an exclusive licensing agreement for the commercialization of Bildyos (HLX14) and a pertuzumab biosimilar (HLX11) in global markets outside of China. This agreement included an upfront payment of $73 million and potential milestone payments of up to $541 million based on development and commercialization milestones. With the approval in the key European market, the achievement of these milestones is expected to accelerate, which will undoubtedly provide both companies with immediate revenue growth and financial stability.
The European approval of Bildyos, a denosumab biosimilar targeting the $4.4 billion original drug Prolia market, will serve as a short-term catalyst for driving global commercial revenue for Organon (OGN) and Shanghai Henlius Biotech (2696.HK). In particular, the demonstration of perfect equivalence to Prolia (5.90%) with a lumbar spine bone mineral density change rate of 6.10% in the Phase 3 clinical trial provides a reliable basis for promoting physician switching and securing marketing advantages in the European market. In the medium to long term, Organon's established global distribution network and the $541 million partnership deal structure are expected to be key variables in maximizing profitability amidst competition with other biosimilars, including Jubbonti from Sandoz. Given that the original developer, Amgen (AMGN), has already experienced a sharp 32% decline in denosumab franchise sales in the first quarter of 2026, the full-scale entry of Bildyos into the European market will accelerate the shift in the global autoimmune and bone disease market.
Source: EMA (ema)