Alvotech's AVT03 Wins European Clearance: A Major Step In Making Denosumab Treatments More Accessible

Alvotech (ALVO) has received authorization from the European Commission for AVT03, marking a significant milestone for denosumab biosimilar therapy across Europe. The approval encompasses two distinct formulations: a 60 mg/mL pre-filled syringe variant for osteoporosis and bone loss management, and a 70 mg/mL vial for preventing skeletal-related events in advanced malignancies affecting bone. This dual-indication approval addresses critical treatment gaps in both rheumatology and oncology supportive care.

Market Opportunity And Clinical Significance

The European denosumab market represents approximately $1.2 billion in annual value, reflecting the substantial demand for treatments addressing osteoporosis in postmenopausal women and men facing fracture risk, as well as skeletal traction considerations in advanced cancer patients. The availability of a lower-cost biosimilar option carries meaningful implications for healthcare systems and patient access across the continent. Prolia and Xgeva—both anchored on the denosumab active ingredient—remain cornerstone therapies for managing bone loss and preventing skeletal complications in cancer patients.

Rigorous Data Package Supports Approval

The regulatory decision was underpinned by comprehensive clinical evidence, including comparative analytical assessments, pharmacokinetic and pharmacodynamic profiling, and confirmatory efficacy trials. Data demonstrated that AVT03 matches the reference products in efficacy, safety, and immunogenicity profiles, meeting the stringent requirements for biosimilar authorization in Europe.

Commercial Strategy And Distribution

Market penetration will proceed through established pharmaceutical partnerships. STADA will distribute the product under the brand names Kefdensis (for osteoporosis indication) and Zvogra (for cancer-related skeletal protection), while a pharmaceutical partner will commercialize it as Acvybra and Xbonzy respectively. This multi-partner approach optimizes market coverage and patient reach across European nations.

Global Expansion Timeline

Beyond Europe, AVT03 has already secured Japanese regulatory authorization (September 2025) as DENOSUMAB BS 120 mg/1.4 mL. In North America, the FDA accepted the 351(k) Biologics License Application in March 2025, filed jointly by Alvotech and its development partner, covering all indications from the reference medications. Alvotech retains manufacturing responsibility while the partner handles registration and market distribution in the U.S.

Broader Portfolio Context

This European approval extends Alvotech’s established track record in the biosimilar space, building on previously authorized therapies targeting TNF-alpha inhibitors and interleukin-23 inhibitors. CEO Robert Wessman emphasized that the authorization reflects the company’s end-to-end biosimilar development capabilities and commitment to scaling high-quality therapeutic options.

ALVO stock has traded between $4.70 and $13.70 over the trailing twelve months, closing the recent trading session at $5.14, representing a 1.58% gain.