{"id":46858,"date":"2025-11-12T15:32:39","date_gmt":"2025-11-12T07:32:39","guid":{"rendered":"https:\/\/flcube.com\/?p=46858"},"modified":"2025-11-12T15:32:40","modified_gmt":"2025-11-12T07:32:40","slug":"shanghai-henlius-biotech-secures-uk-mhra-approval-for-denosumab-biosimilars-bildyos-bilprevda","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=46858","title":{"rendered":"Shanghai Henlius Biotech Secures UK MHRA Approval for Denosumab Biosimilars BILDYOS & BILPREVDA"},"content":{"rendered":"\n

Shanghai Henlius Biotech, Inc.<\/strong> (HKG: 2696<\/a>) announced that the United Kingdom\u2019s Medicines and Healthcare Products Regulatory Agency (MHRA)<\/strong> has granted marketing authorisation<\/strong> for its two denosumab biosimilars, BILDYOS<\/strong> and BILPREVDA<\/strong>. The authorisation covers all approved indications<\/strong> of the reference products (Amgen\u2019s Prolia\u00ae and Xgeva\u00ae).<\/p>\n\n\n\n

Product Portfolio<\/h2>\n\n\n\n
Biosimilar<\/th>Reference Product<\/th>Indication Highlights<\/th><\/tr><\/thead>
BILDYOS<\/strong><\/td>Prolia (denosumab 60\u202fmg)<\/td>\u2022 Osteoporosis in post\u2011menopausal women & men at high fracture risk
\u2022 Bone loss from hormone ablation in prostate\u2011cancer patients
\u2022 Glucocorticoid\u2011induced bone loss in adults<\/td><\/tr>
BILPREVDA<\/strong><\/td>Xgeva (denosumab 120\u202fmg)<\/td>\u2022 Prevention of skeletal\u2011related events in adults with advanced bone\u2011involved malignancies
\u2022 Treatment of unresectable giant\u2011cell tumour of bone (adults & skeletally mature adolescents)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Regulatory Rationale<\/h2>\n\n\n\n