Business-Biosimilars-ReliPoietin

Erythropoietin (EPO) belongs to the class of Erythropoiesis Stimulating Agents, i.e it work as a growth hormone and stimulates production of red blood cells from the hematopoietic stem cells in the bone marrow. It is solely produced by the kidney cells, and thus, any functional damage to the kidneys can result in EPO deficiency and reduction in production of RBC pool that eventually leads to anemia.

ReliPoietin is erythropoietin alpha, conventionally used to reverse anemic condition that is arising because of body's inability to produce required amount of erythropoietin, and thus, reduced pool of red blood cells. It is used as a support therapy in the treatment of Acute, chronic and end-stage renal failure; in cancer-induced and chemotherapy-related anemia; in patients undergoing major surgeries; and in AIDS patients on zidovudine treatment. The aim of therapy is to reduce the number of dialysis required by the renal failure patients, better tolerance of chemotherapy and reduced number of blood transfusions in case of cancer patients; and overall improved quality of life in these patients.

ReliPoietin, is a glycoprotein containing 165 amino acids. The molecular weight is 30 kD, with 40% glycosylation. The upstream processing including the cell lines (Chinese Hamster Ovary) used and the downstream processing yields erythropoietin that is exactly similar to the innovator's product. Even the isoform distribution, which is one of the determinants of efficacy, is same as that of the innovator's product and the biological reference protein.

ReliPoietin is available as pre-filled syringes in the strengths of 2000, 3000, 4000, 6000, 10,000 and 40,000 IU