FDA Approves Epoetin Alfa-Epbx as a Biosimilar to Epoetin Alfa

On May 15, 2018, the U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit™) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia due to chronic kidney disease in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

The approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity between Epoetin alfa-epbx and U.S.-licensed Epoetin alfa demonstrating that Epoetin alfa-epbx is highly similar to US-licensed Epoetin alfa and that there are no clinically meaningful differences between the products. Epoetin alfa-epbx has not been shown to be interchangeable with U.S.-licensed Epoetin alfa.

Like Epoetin alfa, the labeling for Epoetin alfa-epbx contains a Boxed Warning to alert health care professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

The approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity between Epoetin alfa-epbx and U.S.-licensed Epoetin alfa demonstrating that Epoetin alfa-epbx is highly similar to US-licensed Epoetin alfa and that there are no clinically meaningful differences between the products. Epoetin alfa-epbx has not been shown to be interchangeable with U.S.-licensed Epoetin alfa.

Like Epoetin alfa, the labeling for Epoetin alfa-epbx contains a Boxed Warning to alert health care professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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