# Alvotech's Denosumab Biosimilar Wins EU Approval—What It Means For The €1.2B Market

Alvotech just got the green light from the European Commission for AVT03, a biosimilar that targets both Amgen's Prolia (osteoporosis treatment) and Xgeva (cancer bone complications). Here's why this matters:

**The Market Opportunity**
Europe's denosumab market is sitting at roughly €1.2 billion annually. AVT03 could capture a meaningful slice by offering a lower-cost alternative to the originator products. The approval covers two formulations—60 mg for osteoporosis, 70 mg for cancer-related bone events.

**Clinical Backing**
The approval isn't just rubber-stamping. It's backed by comparative studies showing AVT03 matches the original on efficacy, safety, and immunogenicity. That's the gold standard for biosimilar sign-offs.

**Go-To-Market Strategy**
Alvotech handed commercialization to two partners: STADA (marketing as Kefdensis and Zvogra) and Dr. Reddy's (selling as Acvybra and Xbonzy). This dual-track approach could accelerate market penetration across different European healthcare systems.

**What's Next**
The U.S. FDA already has the BLA on file (accepted March 2025). Japan approved a version in September 2025. Alvotech is building a multi-geography biosimilar play—Humira and Stelara biosimilars are already approved. Stock's been volatile: $4.70-$13.70 range over 12 months, closed last trading at $5.14.

For investors: This is a validation of Alvotech's development platform, but biosimilar margins are typically tight and competition can be fierce once the patent cliff hits.