Organon NV

Shanghai Henlius Biotech Receives FDA Approval for Two Denosumab Biosimilars for Osteoporosis Treatment

- Shanghai Henlius Biotech has received FDA approval for two denosumab biosimilars, BILDYOS and BILPREVDA, marking the company's sixth overseas product approval. - The biosimilars are approved for eight indications related to osteoporosis and bone conditions, specifically targeting postmenopausal women at high risk for fractures. - FDA approval was based on comprehensive comparative studies demonstrating similarity to the reference product Prolia in quality, safety, and efficacy. - The products will be commercialized outside China through a partnership with Organon LLC, expanding the company's global market reach.