Last update 26 Oct 2025

Darbepoetin Alfa (Mylan EPD LLC)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Darbepoetin alfa, Darbepoetin Alfa (Genetical Recombination), CKD-11101J
+ [1]
Target
EPO receptor
Action
agonists
Mechanism
EPO receptor agonists(Erythropoietin receptor agonists)
Therapeutic Areas
Hemic and Lymphatic Diseases
Active Indication
Anemia of renal disease
Inactive Indication-
Originator Organization
Viatris Healthcare GK
Active Organization
Viatris Healthcare GmbHViatris Healthcare GK
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
Japan (20 Sep 2019),
Anemia of renal disease
Regulation-
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Structure/Sequence

Related

1
Clinical Trials associated with Darbepoetin Alfa (Mylan EPD LLC)
KCT0003999
/ RecruitingNot ApplicableIIT
Safety and efficacy of monthly administration of darbepoetin alfa compared to the methoxy polyethylene glycol-epoetin beta in the treatment of anemia associated with chronic kidney disease in non-dialysis patients
100 Clinical Results associated with Darbepoetin Alfa (Mylan EPD LLC)
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100 Translational Medicine associated with Darbepoetin Alfa (Mylan EPD LLC)
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100 Patents (Medical) associated with Darbepoetin Alfa (Mylan EPD LLC)
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100 Deals associated with Darbepoetin Alfa (Mylan EPD LLC)
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia of renal disease
Japan
Viatris Healthcare GmbH
20 Sep 2019
Anemia of renal disease
Japan
Viatris Healthcare GK
20 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
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Translational Medicine

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Deal

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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.
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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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