Alvotech's Denosumab Biosimilar Receives European Green Light, Marking Major Win in Affordable Bone Care Market

The European Commission has granted regulatory clearance for AVT03, Alvotech’s (ALVO) biosimilar targeting denosumab-based therapies across the continent. This breakthrough addresses a substantial market opportunity, with Europe’s denosumab market generating approximately $1.2 billion in annual revenue. The dual-indication approval positions AVT03 to capture significant share within the osteoporosis and oncology supportive care segments.

Comprehensive Approval Covering Two Critical Therapeutic Areas

AVT03 gains approval in dual formulations designed for distinct patient populations. The 60 mg/mL single-use pre-filled syringe variant serves as a Prolia biosimilar, targeting osteoporosis and bone loss management in postmenopausal women and male patients with elevated fracture risk. Patients receiving long-term corticosteroid therapy also benefit from this formulation. The second presentation—a 70 mg/mL single-use vial—functions as an Xgeva biosimilar, designed to prevent skeletal-related events in advanced cancer patients with bone metastasis and to address giant cell tumor of bone in adults and skeletally mature adolescents. For cancer patients requiring skeletal traction control during treatment, this formulation provides a cost-effective alternative to original therapies.

Rigorous Development Foundation Underpinning Regulatory Success

The approval draws support from extensive clinical validation. Alvotech’s submission package encompassed comparative analytical assessments, pharmacokinetic and pharmacodynamic profiling, alongside confirmatory efficacy trials. Regulatory reviewers verified that AVT03 demonstrates equivalent efficacy, safety profiles, and immunogenicity characteristics relative to reference products. This comprehensive evidence package reflects the company’s commitment to biosimilar quality standards.

Strategic Partnership Architecture Enabling Market Penetration

Commercialization strategy leverages established pharmaceutical networks. STADA assumes European marketing responsibilities under brand names Kefdensis (Prolia biosimilar) and Zvogra (Xgeva biosimilar). Concurrently, Dr. Reddy’s markets identical formulations as Acvybra and Xbonzy respectively. This dual-partner approach democratizes geographic reach and accelerates patient access across fragmented European healthcare systems.

Expanding Global Regulatory Footprint

Beyond European achievement, AVT03 secured Japanese regulatory approval in September 2025, distributed as DENOSUMAB BS 120 mg/1.4 mL (Ranmark biosimilar). Stateside, the FDA accepted Alvotech and Dr. Reddy’s joint 351(k) Biologics License Application in March 2025, encompassing all Prolia and Xgeva indications. Development and manufacturing responsibilities remain with Alvotech, while Dr. Reddy’s manages registration and commercialization activities.

Reinforcing Alvotech’s Biosimilar Portfolio Leadership

This approval strengthens Alvotech’s existing pipeline, which already includes approved biosimilars targeting Humira and Stelara. The company demonstrates consistent execution across its end-to-end platform, establishing credibility within competitive biosimilar development. Robert Wessman, Chairman and CEO, stated: “This approval reflects the strength of our comprehensive biosimilar platform and our capability to manufacture high-quality therapeutics at commercial scale. This regulatory achievement will substantially expand patient access to essential treatments for osteoporosis and cancer-related bone complications throughout Europe.”

Market Reception and Stock Performance Metrics

ALVO shares have fluctuated between $4.70 and $13.70 over the preceding twelve months. Friday’s closing price settled at $5.14, representing a 1.58% session gain. The stock’s performance reflects broader biosimilar sector dynamics amid ongoing FDA and EMA approvals within the immunology and oncology spaces.

Disclaimer: The views expressed herein represent the author’s perspective and do not necessarily reflect Nasdaq, Inc.'s official positions.