Stada has received marketing authorisations from the European Commission (EC) for its Kefdensis® and Zvogra® denosumab biosimilars.
These approvals for the same indications, route of administration and dosing regimen as the Prolia® (bone health) and Xgeva® (oncology) reference medicines1 mark a crucial step in enabling STADA to improve patient access to biological treatments for bone and oncologic conditions affecting millions of Europeans.
The EC approvals follow positive opinions adopted in September 2025 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)2.
The denosumab authorisations take Stada’s approved biosimilars portfolio in Europe to 10: teriparatide in bone health; bevacizumab in oncology; epoetin in nephrology and oncology; adalimumab, tocilizumab and ustekinumab in immunology; and aflibercept and ranibizumab in ophthalmology, plus the two denosumab authorisations.
Across all indications, the European denosumab market is currently valued at approximately €1 billion. Biosimilar competition to Prolia® and Xgeva® upon anticipated expiry of European Union exclusivity rights during Q4 2025 is expected to expand patient access considerably at lower overall costs.
To meet these patient needs, Stada formed a strategic partnership, whereby Alvotech is responsible for the development and manufacturing of the denosumab biosimilars ̵ also referred to as AVT03 ̵ at its state-of-the-art facility in Reykjavik, Iceland. As marketing authorisation holder, Stada holds commercial rights in Europe, as well as in selected countries in Central Asia and the Middle East. The two companies have already collaborated to bring a high-concentration adalimumab biosimilar and the first EU- approved ustekinumab biosimilar to patients across Europe.
References
1. Union Register of medicinal products – Public health – European Commission
2. STADA further builds its bone-health and oncology offering | STADA
4. Bone health in cancer: ESMO Clinical Practice Guidelines – Annals of Oncology
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