Who are US-licensed Prolia (Amgen)'s main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Denosumab (Prolia), Placebo to Denosumab, Xgeva®, Denosumab De-escalation, Romosozumab followed by Denosumab, Denosumab Prefilled Syringe [Prolia].

How often does this brief refresh?

Every 30 minutes from primary sources (FDA, EMA, MHRA, PMDA, ClinicalTrials.gov, USPTO). Subscribe to the RSS feed below for push alerts.

How do I get this as a recurring report?

Subscribe to /feed/ci/us-licensed-prolia-amgen.xml in any RSS reader (Feedly, Inoreader, NewsBlur). Every regulatory action, trial readout, or patent event lands in your feed automatically.

Last reviewed 2026-06-10 · How we verify

US-licensed Prolia (Amgen) — Competitive Intelligence Brief

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

US-licensed Prolia (Amgen) (US-licensed Prolia (Amgen)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Denosumab. Area: Osteoporosis.

phase 3 Denosumab RANKL Osteoporosis Small molecule Live · refreshed every 30 min

Target snapshot

US-licensed Prolia (Amgen) (US-licensed Prolia (Amgen)) — Fresenius Kabi SwissBioSim GmbH. Prolia is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target
US-licensed Prolia (Amgen) TARGET	US-licensed Prolia (Amgen)	Fresenius Kabi SwissBioSim GmbH	phase 3	Denosumab	RANKL
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)
Placebo to Denosumab	Placebo to Denosumab	Amgen	marketed	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)
Denosumab De-escalation	Denosumab De-escalation	National Taiwan University Hospital	marketed	RANKL inhibitor monoclonal antibody de-escalation strategy	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)
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)

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 (Denosumab class)

Celltrion · 1 drug in this class
Fresenius Kabi SwissBioSim GmbH · 1 drug in this class

Subscribe to ongoing alerts

Push every new event for this competitive set into your RSS reader, IFTTT/Zapier workflow, or email digest:

Cite this brief

Drug Landscape (2026). US-licensed Prolia (Amgen) — Competitive Intelligence Brief. https://druglandscape.com/ci/us-licensed-prolia-amgen. Accessed 2026-06-10.

Build your own brief

Pick any drug + add comparators:

https://druglandscape.com/ci/{slug} — auto-detected competitors
https://druglandscape.com/ci/{slug}?vs=drug1,drug2,drug3 — explicit comparators
Brand names auto-resolve: /ci/keytruda → 301 → /ci/pembrolizumab

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing