- U.S. Food and Drug Administration (FDA) (https://voice.ons.org/topic/us-food-and-drug-administration-fda)
- Oncology drug research (https://voice.ons.org/topic/oncology-drug-research)
- Chemotherapy (https://voice.ons.org/topic/chemotherapy)
- Clinical practice (https://voice.ons.org/topic/clinical-practice)
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 (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf) 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 (http://www.fda.gov/medwatch/report.htm) or by calling 1-800-FDA-1088.
Health care professionals should review the prescribing information (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf) 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 (http://www.fda.gov/medwatch/report.htm) or by calling 1-800-FDA-1088.
In collaboration with the FDA and as a service to our members, ONS provides updates on recent FDA approvals and other important FDA actions (e.g., updated safety information, new prescribing information) pertaining to therapies for patients with cancer. This allows the agency to inform oncologists and professionals in oncology-related fields in a timely manner. Included in the FDA updates is a link to the product label or to other sites for additional relevant clinical information. In supplying this information, ONS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.