Aranesp® (darbepoetin alfa)

BL 103951

Aranesp® (darbepoetin alfa)

BL 103951

U.S. License Holder:

Amgen

Date of License:

September-17-2001

Last Update:

Nov-15-2024

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)

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). 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 (www.fda.gov). 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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