Shots:
- The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product
- Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab
- In 2022, Henlius granted Organon exclusive global commercialization rights (ex-China) for multiple biosimilars, incl. Bildyos & Bilprevda, under a license & supply agreement
Ref: Henlius| Image: Henlius & Organon | Press Release
Related News:- Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)
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