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# FDA Approves Hospira’s Epogen Biosimilar
- URL: https://www.fdaweb.com/fda-approves-hospiras-epogen-biosimilar/
- Published: 2018-05-15T12:00:00.000Z
- Updated: 2026-09-15T00:05:23.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5141445

FDA has approved a Hospira BLA for Retacrit (epoetin alfa-epbx), the first biosimilar version of Amgen’s Epogen/Procrit (epoetin alfa) for treating anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. Approval is based on an agency review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data, an FDA notice says. It notes that the product is not approved as [interchangeable](http://email.prnewswire.com/wf/click?upn=b-2FPGCXvbwOH6TmOuXQHVJU8033gunpiHGgnuRTh0Q2YA8PfgrXAmHhcKghIH2I8xoQyvMg8nhRvDirHrBLGwzmHU2FJfB1H-2Fj3frdDhjKxgxUtRBR4bBwdyOSnUoZbim3TdwR-2FwaM9WO1F8mYRy6QMNTJGYF4-2BmaOsZvrf1DlhE9zyCO0i0A4MpbPaXL0pPtnNajSyYa305UxOk6wNUQTMzDJK-2BNAFXVrUeFDzLcScQ-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuLkOIM-2B0cmt1jevfDDF48JF0G5OXiAE3V9jJjNfXtnrM-2FRpYHK-2FwiWy0rTZYNZcZ0wtWkH7R6Y3wyFNBjybtn9gy9Ydf-2FjSbOzmI03X0nrB5D6tdYqeNPY5ZBDRV41LVgeCrSxYXGF-2B-2FAqdD8p6i3shsD0mMs4UCV3nmogB-2BWq5041i4Kpz6tRsSbf9jq7leI126kHSHz2R7czr5g-2FSjKqokwhCI-2BdJ9DjD6RuukM4FjdYLiohAQnXgdtg7zEkBE0&ref=fdaweb.com) to Epogen/Procrit.

Like the innovator product, Retacrit must be dispensed with a patient Medication Guide that provides information about the drug’s uses and risks. It also contains a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke and tumor growth or recurrence. Additional warnings include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and severe skin reactions.