Organon, Shanghai Henlius Say EU Approves Denosumab Biosimilars

MT Newswires Live

09/19

Organon (OGN) and partner Shanghai Henlius Biotech said Friday the European Commission granted marketing authorization for the Bildyos and Bilprevda injections, denosumab biosimilars to Prolia and Xgeva.

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

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

Prolia and Xgeva are trademarks registered in Europe by Amgen (AMGN).

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