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Prolia biosimilars

Complete Prolia (DENOSUMAB) biosimilar landscape: 6 approved biosimilars, 0 filed, 6 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

6 approved 0 filed 6 Phase 3 All key patents expired

About Prolia

Prolia (DENOSUMAB) — originally marketed by Amgen. Class: RANK Ligand Inhibitor [EPC]. Target: Tumor necrosis factor ligand superfamily member 11. Area: Oncology. First approved 2010-01-01.

Approved biosimilars (6)

BiosimilarSponsorPhaseFirst approvalCountry
Denosumab treatment in osteoporotic patients Shinshu University marketed
JUBBONTI SANDOZ INC marketed
Denosumab De-escalation National Taiwan University Hospital marketed
Denosumab Prefilled Syringe [Prolia] Seoul National University Bundang Hospital marketed
Denosumab (Prolia) Prince of Wales Hospital, Shatin, Hong Kong marketed
BONCRESA AMNEAL PHARMS LLC marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (6)

BiosimilarSponsorPhaseFirst approvalCountry
Denosumab (CP2) Amgen phase 3
Denosumab (CP4) Amgen phase 3
Denosumab (AMG 162) Amgen phase 3
Denosumab (standard dosing) Swiss Cancer Institute phase 3
Denosumab (reduced dosing) Swiss Cancer Institute phase 3
Denosumab-Ref Lambda Therapeutic Research Ltd. phase 3

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

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Every regulatory action on Prolia or any of its biosimilars:

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