Drugs / EU-Prolia
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EU-Prolia

also known as denosumab · Prolia
Developed for
postmenopausal osteoporosis

Trials 0

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Comparator or background therapy1 trial
Phase 3 NCT03974100 Comparator Jul 2019 → Apr 2022 postmenopausal osteoporosis Sandoz Completed Met primary

Press releases naming this drug 112 releases

DateIssuerRelease
2026-09-28 Teva Branded Pharmaceutical Products R&D, Inc. Teva Continues Biosimilar Momentum with U.S. FDA Approval of DEGEVMA™ (denosumab-adet), a Biosimilar to Xgeva® (denosumab) tevapharm.com ↗
2026-09-28 Teva Branded Pharmaceutical Products R&D, Inc. Teva Continues Biosimilar Momentum with U.S. FDA Approval of DEGEVMA™ (denosumab-adet), a Biosimilar to Xgeva® (denosumab) tevapharm.com ↗
2026-06-24 Shanghai Henlius Biotech Organon CANADA and henlius Expand Access to Denosumab Treatments With LAUNCH OF BILDYOS® (Denosumab Injection) and TUZEMTY® (Denosumab Injection), Biosimilars to PROLIA and XGEVA henlius.com ↗
2026-04-07 Apotex Inc. Apotex Strengthens Osteoporosis Care in Canada with Health Canada's Approval of DENOZA™, a Denosumab Biosimilar apotex.com ↗
2026-03-30 Teva Branded Pharmaceutical Products R&D, Inc. Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com ↗
2026-03-30 Teva Branded Pharmaceutical Products R&D, Inc. Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com ↗
2026-03-24 Shanghai Henlius Biotech Health Canada Approves Henlius’ BILDYOS® (Denosumab Injection) and TUZEMTY® (Denosumab Injection), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively henlius.com ↗
2026-01-19 Roxane Laboratories Hikma announces launch of Enoby™ (denosumab- qbde) and Xtrenbo™ (denosumab- qbde) referencing Prolia® and Xgeva® respectively hikma.com ↗
2025-12-22 Impax Laboratories, LLC Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA® amneal.com ↗
2025-12-02 Shanghai Henlius Biotech Henlius’ Denosumab HLX14 New Drug Application Accepted by NMPA henlius.com ↗
2025-12-01 Fresenius Kabi Fresenius Launches Denosumab Biosimilars in EU fresenius.com ↗
2025-12-01 Fresenius Kabi Fresenius Launches Denosumab Biosimilars in EU fresenius.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as EU-Prolia ClinicalTrials.gov intervention name — accepted as the source's own label NCT03974100 ↗
Known as denosumab “between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab)” NCT03974100 ↗
Known as Prolia “EU-Prolia (EU-authorized Prolia®)” NCT03974100 ↗
Route Subcutaneous “60 mg /mL subcutaneous injection every 6 months” NCT03974100 ↗