hetero drugs biosimilarnews logo Hetero launches darbepoetin alfa biosimilar in India
The Hetero Group, one of the largest manufacturers and suppliers of activepharmaceutical ingredients to the Indian pharmaceutical industry, yesterdayannounced the launch of its first biosimilar product in India, darbepoetin alfa.
This launch marks a significant advancement for Hetero in a biosimilars market expected to grow to US$ 24B in the next five years. In partnership with several prominent pharmaceutical companies, Hetero is launching the drug across India.
http://www.biosimilarnews.com/hetero-launches-darbepoetin-alfa-biosimilar-in-india june 19 2014
Darbepoetin alfa (rINN) /dɑrbəˈpɔɪtɨn/ is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood celllevels) and is used to treat anemia, commonly associated with chronic renal failure and cancer chemotherapy. Darbepoetin is marketed by Amgen under the trade name Aranesp.
The drug was approved in September 2001 by the Food and Drug Administration for treatment of anemia in patients with chronic renal failure by intravenous or subcutaneous injection. In June 2001, it had been approved by the European Medicines Agency for this indication as well as the treatment of anemia in cancer patients undergoing chemotherapy.
Dr. Reddy’s Laboratories launched darbepoetin alfa in India under the brand name ‘Cresp’ in August 2010. This is the world’s first generic darbepoetin alfa. Cresp has been approved in India.
Human erythropoietin with 2 aa substitutions to enhance glycosylation (5 N-linked chains), 165 residues (MW=37 kD). Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Darbepoetin is produced by recombinant DNA technology in modified Chinese hamster ovary cells. It differs from endogenous erythropoietin (EPO) by containing two more N-linked oligosaccharide chains. It is an erythropoiesis-stimulating 165-amino acid protein.