U.S. License Holder:
Date of License:
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 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
CKD-11101 (Chong Kun Dang Pharmaceutical) (December-2018)