Prolia® (Denosumab) — Competitive Intelligence Brief

Prolia® (Denosumab) (Prolia® (Denosumab)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Monoclonal antibody. Area: Osteoporosis, Bone-related disorders.

phase 3 Monoclonal antibody RANKL Osteoporosis, Bone-related disorders Small molecule

Target snapshot

Prolia® (Denosumab) (Prolia® (Denosumab)) — Samsung Bioepis Co., Ltd.. Prolia works by binding to RANKL, a protein involved in the formation and activation of osteoclasts, which are cells that break down bone.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Prolia® (Denosumab) TARGET	Prolia® (Denosumab)	Samsung Bioepis Co., Ltd.	phase 3	Monoclonal antibody	RANKL
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)
BONCRESA	DENOSUMAB-MOBZ	AMNEAL PHARMS LLC	marketed	RANK Ligand Inhibitor [EPC]	RANKL
Xgeva®	Xgeva®	Jiangsu Hansoh Pharmaceutical Co., Ltd.	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)
Romosozumab followed by Denosumab	Romosozumab followed by Denosumab	National Taiwan University Hospital	marketed	Sclerostin inhibitor followed by RANKL inhibitor	Sclerostin (romosozumab); RANKL (Denosumab)
Romosozumab and Denosumab Cycle Therapy	Romosozumab and Denosumab Cycle Therapy	National Taiwan University Hospital	marketed	Bone-forming agent and antiresorptive agent combination therapy	Sclerostin (romosozumab); RANKL (denosumab)

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 (Monoclonal antibody class)

1. Pfizer · 7 drugs in this class
2. argenx · 7 drugs in this class
3. Johnson & Johnson · 2 drugs in this class
4. German CLL Study Group · 2 drugs in this class
5. Amgen · 2 drugs in this class
6. Hoffmann-La Roche · 2 drugs in this class
7. Brii Biosciences Limited · 2 drugs in this class
8. Alexion Pharmaceuticals, Inc. · 2 drugs in this class
9. Biotest · 2 drugs in this class
10. Fondazione Italiana Linfomi - ETS · 2 drugs in this class