Biosimilar Market Expansion in Europe: Regulatory Momentum and Competitive Positioning in the Denosumab Space

The European biosimilars market is undergoing a transformative phase, driven by regulatory advancements and intensifying competition. The recent European Commission (EC) approval of BILDYOS® (Henlius) and BILPREVDA® (Organon) as denosumab biosimilars in September 2025 underscores this momentum, signaling a pivotal moment for the sector. These approvals, alongside eight additional denosumab biosimilars recommended by the EMA's Committee for Medicinal Products for Human Use (CHMP) in April 2025, reflect a maturing regulatory framework and a rapidly diversifying competitive landscapeEuropean Commission (EC) Approves Henlius and Organon’s BILDYOS and BILPREVDA Biosimilars^[1]. For investors, this dynamic environment presents both opportunities and challenges, particularly as cost pressures and therapeutic demand converge.

Regulatory Momentum: A Catalyst for Market Growth

Europe remains the global leader in biosimilar adoption, accounting for over 50% of global biosimilar use in 2025Biosimilars Trends to Know in 2025: Europe’s Dominance, South Korea’s Rise and the Growing Development Gap^[2]. This dominance is fueled by the region's cost-conscious healthcare systems, where biosimilars offer savings of 15–35% compared to reference biologicsBiosimilars Trends to Know in 2025: Europe’s Dominance, South Korea’s Rise and the Growing Development Gap^[2]. The EMA's rigorous yet streamlined approval process has further accelerated market entry, with cross-border collaborations playing a critical role. For instance, 45% of biosimilar approvals in Europe between 2014 and 2024 involved partnerships with firms from India and South KoreaBiosimilars Trends to Know in 2025: Europe’s Dominance, South Korea’s Rise and the Growing Development Gap^[2]. The joint development of BILDYOS and BILPREVDA by Henlius (China) and Organon (Netherlands) exemplifies this trend, leveraging global expertise to meet EU standardsEuropean Commission (EC) Approves Henlius and Organon’s BILDYOS and BILPREVDA Biosimilars^[1].

However, regulatory hurdles persist. While the EMA affirmed interchangeability for biosimilars in 2022, the U.S. requires costly clinical trials to establish this status—a distinction that may influence European market dynamics as biosimilars compete with reference products like Amgen's Prolia and XgevaBiosimilars Trends to Know in 2025: Europe’s Dominance, South Korea’s Rise and the Growing Development Gap^[2]. Despite these challenges, the EC's swift approvals of denosumab biosimilars in 2025 suggest a regulatory environment increasingly open to innovation, provided developers can demonstrate robust biosimilarity dataEuropean Commission (EC) Approves Henlius and Organon’s BILDYOS and BILPREVDA Biosimilars^[1].

Competitive Positioning: A Crowded but Lucrative Arena

The denosumab market is now one of the most contested in Europe. With BILDYOS and BILPREVDA joining eight other CHMP-approved biosimilars, the therapeutic landscape is set to become highly fragmentedEuropean Commission (EC) Approves Henlius and Organon’s BILDYOS and BILPREVDA Biosimilars^[1]. This surge in competition is partly driven by the aging population and rising osteoporosis prevalence, which are projected to expand the market for bone-targeting therapiesDenosumab Race Heats Up In Europe With Eight More Nods^[3]. For instance, BILDYOS targets postmenopausal osteoporosis and glucocorticoid-induced bone loss, while BILPREVDA addresses skeletal-related events in advanced cancers—indications that align with significant unmet medical needsEuropean Commission (EC) Approves Henlius and Organon’s BILDYOS and BILPREVDA Biosimilars^[1].

South Korea's biosimilars sector is emerging as a dominant force in this space. Companies like Samsung Bioepis and Celltrion have secured multiple global approvals, leveraging their manufacturing expertise to undercut pricing and capture market shareBiosimilars Trends to Know in 2025: Europe’s Dominance, South Korea’s Rise and the Growing Development Gap^[2]. This international competition pressures European and U.S. firms to innovate or risk marginalization. Henlius and Organon's entry, however, highlights the strategic value of partnerships in navigating regulatory and commercial barriersEuropean Commission (EC) Approves Henlius and Organon’s BILDYOS and BILPREVDA Biosimilars^[1].

Investment Implications: Balancing Opportunity and Risk

For investors, the European biosimilars market offers a compelling mix of growth and risk. The cost advantages of biosimilars, coupled with favorable regulatory trends, position the sector to outperform traditional biologics in the coming yearsBiosimilars Trends to Know in 2025: Europe’s Dominance, South Korea’s Rise and the Growing Development Gap^[2]. However, the development gap—where only 29% of biologics nearing patent expiry have biosimilars in development—remains a concernBiosimilars Trends to Know in 2025: Europe’s Dominance, South Korea’s Rise and the Growing Development Gap^[2]. Denosumab, which generates under €500 million annually in Europe, may fall into this category, as commercial incentives for biosimilar development wane for lower-revenue biologicsBiosimilars Trends to Know in 2025: Europe’s Dominance, South Korea’s Rise and the Growing Development Gap^[2].

Strategic collaborations, as seen with Henlius and Organon, could mitigate these risks by sharing R&D costs and leveraging complementary market access. Additionally, companies that secure interchangeability designations or demonstrate superior patient outcomes may gain a competitive edge in price-sensitive marketsBiosimilars Trends to Know in 2025: Europe’s Dominance, South Korea’s Rise and the Growing Development Gap^[2].

Conclusion

The approval of BILDYOS and BILPREVDA in 2025 is more than a regulatory milestone—it is a harbinger of broader shifts in the European biosimilars market. As regulatory momentum accelerates and competition intensifies, the sector is poised for a new era of innovation and affordability. For investors, the key lies in identifying firms that can navigate the development gap, secure strategic partnerships, and capitalize on the region's cost-driven healthcare priorities. In this evolving landscape, Europe's leadership in biosimilars is not just a trend—it is a transformative force reshaping global biologics markets.