Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

ByRidhi Rastogi 3 days ago

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The US FDA 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 quality, 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: Organon| Image: Henlius & Organon | Press Release

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Written by

Ridhi Rastogi

Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.

View all posts by Ridhi Rastogi

Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Ridhi Rastogi

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