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NEWS

Henlius Reports NMPA NDA Acceptance of 120mg (1.7mL) per Vial Strength of HLX14 (Biosimilar, Denosumab) 

Shots:  The NMPA has accepted NDA for HLX14, a biosimilar version of denosumab, in the 120mg (1.7mL) per vial strength presentation    NDA was based on extensive data, incl. analytical similarity studies, non-clinical & clinical comparative studies, where HLX14 at the 120 mg (1.7 mL) per vial strength showed similarity to its reference drug in terms…
September 11, 2026

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Henlius & Organon
NEWS

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

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…
September 22, 2025

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Henlius & Organon
NEWS

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

Shots: 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,…
September 3, 2025

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