Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)
Shots:
- The US FDA has approved Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products
- Approval is based on P-III trial results in postmenopausal women with osteoporosis, which showed equivalent efficacy & PD of CT-P41 to reference denosumab, with similar PK and comparable safety, and immune response
- As part of a settlement with Amgen, STOBOCLO and OSENVELT are anticipated to launch in the US market in June 2025
Ref: Celltrion | Image: Celltrion
Related News:- Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)
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