Fresenius Kabi's Denosumab Biosimilars: A Game-Changer in Europe's Crowded Biosimilar Landscape

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) approved Fresenius Kabi's denosumab biosimilars, Conexxence (for osteoporosis) and Bomyntra (for oncology-related bone conditions), on May 22, 2025. This marks a pivotal moment for Fresenius Kabi to capitalize on a $6.7 billion market dominated by Amgen's Prolia and Xgeva, but now under threat from a wave of biosimilars. While the EU biosimilar space is already crowded, Fresenius's strategic moves—including a Global Settlement with Amgen, pricing leverage, and a late-mover advantage—position it to carve out meaningful revenue despite the competition. Here's why investors should act now.

The Competitive Landscape: A Fiercely Contested Arena

The EU biosimilar market for denosumab is no longer virgin territory. Competitors like Celltrion (Jubbonti/Wyost), Samsung Bioepis (Eksunbi/Opuviz), and Sandoz (Jubbonti/Wyost) have already secured approvals between 2020 and 2024. Fresenius's entry might seem late, but timing is everything here.

Why Fresenius Still Wins:
1. Settlement-Backed Market Access: The Global Settlement with Amgen, finalized in early 2025, shields Fresenius from litigation and allows a late-2025 EU launch. Competitors like Sandoz and Celltrion faced similar settlements, but Fresenius's late entry means it can avoid the patent fights that delayed earlier entrants.
2. Pricing Power: EU reference pricing rules mean biosimilars typically undercut originators by 30–40%. Fresenius, with its vertically integrated manufacturing, can offer a cost structure that rivals even the most efficient Asian competitors.
3. Indication Breadth: Bomyntra targets advanced malignancies, a niche underserved by some competitors. Conexxence, meanwhile, covers osteoporosis and glucocorticoid-induced bone loss—a broad patient pool.

The Settlement's Hidden Advantage: Delayed Competition, Immediate Revenue

The settlement with Amgen, while requiring Fresenius to delay its launch until late 2025, comes with a critical benefit: no litigation risks. This contrasts with the U.S. market, where Sandoz and Celltrion are still battling Amgen in court. In Europe, Fresenius can focus entirely on commercialization.

The stock's performance since 2020 reflects its biosimilar pipeline's promise. A 2025 EU launch, with Amgen's blessing, could accelerate this trend.

Market Dynamics: Amgen's Decline and Biosimilars' Rise

Amgen's Prolia and Xgeva face a perfect storm:
- Patent Expiry: Key patents for denosumab expire globally by 2025, eliminating Amgen's monopoly.
- Cost Pressure: EU healthcare systems are aggressively pushing biosimilars to cut costs. Denosumab's use in chronic conditions like osteoporosis makes it a prime target.
- Competitor Momentum: The CHMP's May approvals for Fresenius follow a trend of 12 denosumab biosimilars approved in 2025 alone. This saturation will accelerate Amgen's market share erosion.

Revenue Potential: A $1 Billion Opportunity for Fresenius

Fresenius's EU launch could capture 15–20% of the denosumab market by 2027. With Prolia/Xgeva sales in Europe at ~$1.8 billion annually, even modest share gains translate to $270–360 million in annual revenue for Fresenius. Key drivers:
- Hospital Ties: Fresenius's existing relationships with European hospitals (via its drug distribution arm) enable rapid uptake.
- Patient Access: Biosimilars like Conexxence/Bomyntra are likely to be preferred for high-volume therapies.

The EU's biosimilar market has grown at 12% CAGR since 2020. Fresenius's entry aligns with this tailwind.

Risks: Overcrowding and Pricing Pressure

The EU's denosumab market is already flooded. Competitors like Sandoz (with Jubbonti) and Celltrion (with Stoboclo) have years of commercial experience. Fresenius must move quickly to differentiate itself:
- Pricing Aggressiveness: A 40% discount to Prolia could lock in long-term contracts with national healthcare systems.
- Indication Focus: Targeting Bomyntra's oncology niche could avoid direct competition with rivals' osteoporosis-focused biosimilars.

Conclusion: A Strategic Win with Upside

Fresenius Kabi's CHMP approval for Conexxence and Bomyntra is a strategic masterstroke. While the EU biosimilar space is crowded, the company's settlement-backed market access, cost advantages, and indication focus position it to thrive. With Amgen's dominance crumbling and EU healthcare systems hungry for cheaper alternatives, Fresenius is primed to capture a multi-hundred-million-dollar slice of the denosumab market.

Investors should consider Fresenius Kabi a buy now—before the broader market realizes how its late entry could become its greatest strength.

Data sources: EMA, CHMP meeting records, company filings.