The FDA Grants Interchangeability Designation to Celltrion’s Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots:

• The US FDA has granted interchangeable designation to Stoboclo & Osenvelt, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for all approved indications of the reference product
• Designation was based on extensive data, incl. analytical data demonstrating similarity of Stoboclo & Osenvelt with reference product & P-III trial results in postmenopausal women with osteoporosis, which showed comparable efficacy, PK/PD, safety, & immunogenicity
• Stoboclo & Osenvelt were launched in the US in Jul 2025 & are available as 60mg/mL & 120mg/1.7 mL (70mg/mL) injections, respectively

Ref: Celltrion | Image: Celltrion| Press Release

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