Aranesp® (darbepoetin alfa)

BL 103951

Aranesp® (darbepoetin alfa)

BL 103951

U.S. License Holder:


Date of License:


Last Update:


approved_indications FDA-Approved Indications

ARANESP (darbepoetin alfa) is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to:

Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis;

The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Retacrit (epoetin zeta) (Hospira) (December-2007)
Silapo (epoetin zeta) (STADA) (December-2007)

Biosimilars Approved In Japan

CKD-11101 (Chong Kun Dang Pharmaceutical) (September-2019)
DA-3880 (Dong-A ST / Sanwa Kagaku Kenkyusho (SKK)) (September-2019)
Darbepoetin Alfa BS Injection JCR (JCR Pharmaceuticals / Kissei Pharmaceuticals) (September-2019)
Darbepoetin Alfa Injection Syringe [KKF] (Kyowa Hakko Kirin) (August-2018)

Biosimilars Approved In South Korea

Nesbell (Chong Kun Dang Pharmaceutical) (December-2018)


Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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