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Nesbell is a darbepoetin alfa biosimilar erythropoiesis-stimulating agent (ESA) developed by Chong Kun Dang as the world’s first biosimilar to NESP (darbepoetin alfa) for the treatment of anemia associated with chronic kidney disease in patients on hemodialysis or not on dialysis.[1][3][5][6][11][13][14] As a long-acting analog of human erythropoietin with additional N-linked glycosylation, it binds and activates the erythropoietin receptor on erythroid progenitor cells in the bone marrow to stimulate red blood cell production, enabling less frequent dosing than first-generation epoetin products.[11] Phase 1 and Phase 3 studies have demonstrated that CKD-11101 has pharmacokinetic, pharmacodynamic, efficacy, and safety profiles equivalent to originator darbepoetin alfa/NESP in CKD patients, including those on hemodialysis, and it has been approved and marketed in South Korea and Japan, with licensing deals for distribution in multiple Middle Eastern countries.[1][3][4][5][11][13][14]
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