Pfizer anemia biosimilar wins FDA approval

May 15, 2018

Retacrit, the Pfizer biosimilar of anemia treatments from Amgen and Johnson & Johnson, was approved by U.S. Food and Drug Administration on Tuesday.

The approval comes one year after the FDA rejected the copy of Amgen’s Epogen and Johnson & Johnson’s Procrit, as a treatment for a drop in red blood cells caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with HIV. Retacrit was also approved for use before and after surgery to safeguard against the need for red blood cell transfusions due to surgery blood loss.

Last year, an independent panel of FDA advisers recommended the drug's approval, but the agency rejected Retacrit citing issues with a potential Kansas manufacturing site.

Read the Reuters report

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