Organon, Henlius Says US FDA Approves Denosumab Biosimilars

MT Newswires Live

Sep 02

Organon (OGN) and Shanghai Henlius Biotech said Tuesday the US Food and Drug Administration has approved Bildyos 60 mg/mL injection and Bilprevda 120 mg/1.7 mL injection, denosumab biosimilars to Prolia and Xgeva used in the prevention of skeletal-related events in certain cancer patients.

The companies said the approvals cover all indications of the reference products, including treatment of osteoporosis and prevention of skeletal-related events in certain cancer patients.

Under a 2022 agreement, Organon holds exclusive rights to commercialize Bildyos and Bilprevda outside China.

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