EU-Prolia — Competitive Intelligence Brief

EU-Prolia (EU-Prolia) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: RANKL inhibitor (monoclonal antibody). Area: Bone metabolism / Osteoporosis.

phase 3 RANKL inhibitor (monoclonal antibody) RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) Bone metabolism / Osteoporosis Biologic

Target snapshot

EU-Prolia (EU-Prolia) — Luye Pharma Group Ltd.. EU-Prolia is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand) to reduce osteoclast formation and bone resorption.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
EU-Prolia TARGET	EU-Prolia	Luye Pharma Group Ltd.	phase 3	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Xgeva®	Xgeva®	Jiangsu Hansoh Pharmaceutical Co., Ltd.	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
DMAB Discontinuation and Switching	DMAB Discontinuation and Switching	University of Alabama at Birmingham	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Placebo to Denosumab	Placebo to Denosumab	Amgen	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Denosumab (Prolia)	Denosumab (Prolia)	Prince of Wales Hospital, Shatin, Hong Kong	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (receptor activator of nuclear factor kappa-B ligand)
Denosumab Prefilled Syringe [Prolia]	Denosumab Prefilled Syringe [Prolia]	Seoul National University Bundang Hospital	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Denosumab (standard dosing)	Denosumab (standard dosing)	Swiss Cancer Institute	phase 3	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (RANKL inhibitor (monoclonal antibody) class)

1. Amgen · 5 drugs in this class
2. Swiss Cancer Institute · 2 drugs in this class
3. Jiangsu Hansoh Pharmaceutical Co., Ltd. · 1 drug in this class
4. Lambda Therapeutic Research Ltd. · 1 drug in this class
5. Luye Pharma Group Ltd. · 1 drug in this class
6. Prince of Wales Hospital, Shatin, Hong Kong · 1 drug in this class
7. Seoul National University Bundang Hospital · 1 drug in this class
8. University of Alabama at Birmingham · 1 drug in this class
9. mAbxience Research S.L. · 1 drug in this class
10. GlaxoSmithKline · 1 drug in this class