The European Commission (EC) has granted marketing authorization to Celltrion for two denosumab biosimilars, Stobocolo and Osenvelt, referencing Amgen's Prolia and Xgeva respectively. The approval follows comprehensive global Phase 3 trials that demonstrated therapeutic equivalence to the original medications.
The dual approval significantly expands treatment options for patients with bone-related conditions. Stobocolo is indicated for treating postmenopausal osteoporosis and bone loss, while Osenvelt addresses the prevention of bone complications in cancer patients and the treatment of giant cell tumors of the bone.
Clinical Development and Regulatory Progress
Celltrion's regulatory success builds on robust clinical evidence from global Phase 3 trials. The company initiated its European regulatory submission in March 2023, following a development program that confirmed biosimilarity with the reference products. The approval in Europe follows the earlier authorization of both biosimilars in South Korea in November 2023.
Market Impact and Commercial Significance
The denosumab market represents a substantial commercial opportunity, with Amgen's Prolia and Xgeva portfolio generating approximately 9 trillion won ($6.23 billion) in global sales in 2024. Celltrion's entry into this space with cost-effective biosimilar alternatives could significantly impact healthcare economics and patient access to treatment.
Strategic Portfolio Expansion
This latest authorization marks Celltrion's third European biosimilar approval in recent weeks, following the EC clearance of Eydenzelt (aflibercept), their biosimilar version of the ophthalmology drug Eylea. The company is also advancing Avtozma (tocilizumab), a biosimilar of the autoimmune drug Actemra, which has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
The approval of these denosumab biosimilars brings Celltrion closer to completing its 11-product biosimilar portfolio in Europe, matching its achievement in the Korean market. The company's expanding biosimilar portfolio now covers multiple therapeutic areas, including autoimmune diseases, oncology, ophthalmology, and bone disorders, targeting a combined global market valued at approximately 150 trillion won.
