THE US Food and Drug Administration (FDA) on Tues approved the first biosimilar to Amgen's blockbuster Epogen/Procrit (epoetin alfa), bringing the total number of biosimilars approved by the agency to 10.
The biosimilar, called Retacrit (epoetin alfa-epbx), will be marketed by Pfizer's Hospira unit and is approved for the same indications as Epogen/Procrit, including treatment of anemia caused by chronic kidney disease, chemotherapy or use of zidovudine in patients with an HIV infection, and for use before and after surgery to reduce the need for red blood cell transfusions.
Epoetin alfa is marketed in Australia by Janssen-Cilag as Eprex.
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