FDA Approves Epoetin Alfa Biosimilar Retacrit
As with other erythropoiesis-stimulating agents, the labeling for Retacrit contains a Boxed Warning
The Food and Drug Administration (FDA) has approved Retacrit (epoetin alfa-epbx; Pfizer), a biosimilar to Epogen/Procrit (epoetin alfa), for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. It is also indicated to reduce the need for allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
The approval of Retacrit was based on a review of evidence that included human pharmacokinetic/pharmacodynamic data and clinical immunogenicity data which demonstrated a high degree of similarity between Retacrit and its reference product.
“With the approval of Retacrit, healthcare providers now have an additional option to choose from when prescribing an ESA,” said George M. Rodgers, MD, PhD, Professor of Medicine, Division of Hematology and Hematologic Malignancies, Department of Internal Medicine, University of Utah School of Medicine. “By providing potentially more affordable therapeutic options, biosimilar medicines can allow for the reallocation of resources to other areas of cancer care. This is positive news for the oncology community.”
As with other erythropoiesis-stimulating agents (ESAs), the labeling for Retacrit contains a Boxed Warning regarding an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. A Medication Guide that provides information on the uses and risks associated with Retacrit is required when the product is dispensed.
Retacrit will be available in preservative-free, single-dose vials in the following strengths: 2000 Units/mL, 3000 Units/mL, 4000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL.
For more information visit Pfizer.com.