Press Release: STADA obtains approvals to bring denosumab biosimilars in bone-health and oncology to patients in Europe
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STADA obtains approvals to bring denosumab biosimilars in bone-health and oncology to patients in Europe
- European Commission approves STADA’s Kefdensis® and Zvogra® denosumab biosimilars for all indications of reference medicines Prolia® and Xgeva®
- Denosumab approvals complement STADA’s strong offering in bone health, including Europe’s leading teriparatide biosimilar, as well its broad portfolio of oncology medicines such as bevacizumab and epoetin biosimilars, with 10 EU biosimilar approvals in total
- STADA’s Global Specialty Head Ian Henshaw: “These European Commission authorisations pave the way for STADA to broaden patient access to biological treatment for bone conditions affecting millions of people in Europe.”
Bad Vilbel, Germany – 24 November 2025 – 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 medicines 1 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.
“These European Commission authorisations pave the way for STADA to broaden patient access to biological treatment for bone and oncologic conditions affecting millions of people in Europe,” commented STADA’s Global Specialty Head, Ian Henshaw. “With denosumab, we are proud to be adding another European-made biosimilar to our extensive portfolio that includes our market-leading biosimilar teriparatide in osteoporosis, as well as oncology medicines such as bevacizumab and epoetin.”
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.
Kefdensis®, referencing Amgen’s Prolia®, received EC approval for treating osteoporosis in postmenopausal women and in men at increased risk of fractures. Zvogra®, referencing Amgen’s Xgeva®, is authorised for the prevention of skeletal-related events in adults with advanced malignancies involving bone, as well as for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
One in three women and at least one in six men will suffer an osteoporotic fracture in their lifetime, according to the International Osteoporosis Foundation’s Scope ‘21 report 3. For every minute that passes, eight new fracture cases arise in the European Union. It is estimated that more than 23 million men and women are at high risk of osteoporotic fractures in the EU.
Metastatic bone disease is most commonly seen with specific cancer types ̵ notably those with metastasis from the breast (70%), prostate (85%), lung (40%) and kidney (40%) ̵ as well as multiple myeloma (95%). Bone metastases often cause complications, such as pathological fractures, that are associated with loss of mobility and social functioning, reduced quality of life, increased health care expenditure and worse survival 4.
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 authorization 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.
Specialty, including biosimilars, was the fastest-growing of STADA’s three business segments in the first half of 2025, with adjusted constant-currency revenues increasing by 18% to €486 million. This rise was largely attributable to a strong performance and penetration of STADA’s ustekinumab biosimilar launched from July 2024, reinforced by continued broad- based growth of the group’s in-market biosimilars portfolio. Growing patient uptake of innovative nephrology and neurology brands also contributed to the double-digit Specialty revenues growth.
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
About Denosumab
Denosumab is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a protein in the body called RANKL. RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue. By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts. This reduces the loss of bone and maintains bone strength, making fractures less likely to happen. I osteoclast activity stimulated by RANKL is a key mediator of bone destruction in metastatic bone disease. Denosumab binds to RANKL with high affinity and specificity, preventing the interaction between RANKL and RANK. This leads to a reduction in osteoclast numbers and function, and a decrease in bone resorption and cancer-induced bone destruction.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in over 100 countries. In financial year 2024, STADA achieved group sales of € 4.059 billion and adjusted constant-currency earnings before interest, taxes, depreciation and amortization (adj. cc EBITDA) of € 886 million. As of 31 December 2024, STADA employed 11,649 people worldwide.
Additional information for journalists STADA Arzneimittel AG - Media Relations Stadastrasse 2-18, 61118 Bad Vilbel - Germany Phone: +49 (0) 6101 603-165 E-Mail: press@stada.de Or visit us via our website at https://www.stada.com/media/newsroom Follow @stadaGroup on LinkedIn Additional information for capital market participants STADA Arzneimittel AG - Investor & Creditor Relations Stadastrasse 2-18, 61118 Bad Vilbel – Germany Phone: +49 (0) 6101 603-4689 Fax: +49 (0) 6101 603-215 E-mail: ir@stada.de Or visit us via our website at https://www.stada.com/investor-relations/