Last update 27 Mar 2025

Denosumab-bmwo

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Denosumab Biosimilar (Celltrion, Inc.), 地舒单抗生物类似药(Celltrion, Inc.), CT-P41
+ [4]
Target
Action
inhibitors
Mechanism
RANKL inhibitors(Tumor necrosis factor ligand superfamily member 11 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
South Korea (21 Nov 2024),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bone metastases
United States
28 Feb 2025
Hypercalcemia
United States
28 Feb 2025
Multiple Myeloma
United States
28 Feb 2025
Solid tumor
United States
28 Feb 2025
Bone Cancer
European Union
18 Feb 2025
Bone Cancer
Iceland
18 Feb 2025
Bone Cancer
Liechtenstein
18 Feb 2025
Bone Cancer
Norway
18 Feb 2025
Glucocorticoid-induced osteoporosis
European Union
18 Feb 2025
Glucocorticoid-induced osteoporosis
Iceland
18 Feb 2025
Glucocorticoid-induced osteoporosis
Liechtenstein
18 Feb 2025
Glucocorticoid-induced osteoporosis
Norway
18 Feb 2025
Osteoporosis, Postmenopausal
European Union
18 Feb 2025
Osteoporosis, Postmenopausal
Iceland
18 Feb 2025
Osteoporosis, Postmenopausal
Liechtenstein
18 Feb 2025
Osteoporosis, Postmenopausal
Norway
18 Feb 2025
Osteoporotic Fractures
European Union
18 Feb 2025
Osteoporotic Fractures
Iceland
18 Feb 2025
Osteoporotic Fractures
Liechtenstein
18 Feb 2025
Osteoporotic Fractures
Norway
18 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
479
(CT-P41)
gekdehaiwz(pqjptlaavr) = dppybffpxv vqsbkvfeov (dtdwhxvvuz, 0.29977)
-
16 May 2024
US-licensed Prolia
(US-licensed Prolia)
gekdehaiwz(pqjptlaavr) = fofmoxulka vqsbkvfeov (dtdwhxvvuz, 0.32133)
Phase 3
479
CT-P41 60 mg
uxbvwezpuw(kmvaxsmumb) = increased after each dosing and were comparable between groups ywmiqdkhjp (wvjwifbbqe )
Positive
11 Apr 2024
Prolia 60 mg
Phase 3
479
sniipszqce(orcnrmcqny) = increased after each dosing and were comparable between groups naoxynnxqa (rlifvukavn )
Positive
11 Apr 2024
Prolia
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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