Organon, Henlius Says US FDA Approves Denosumab Biosimilars

MT Newswires Live

09/02

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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