FDA approves first epoetin alfa biosimilar for the treatment of anemia

FDA has approved epoetin alfa-epbx (Retacrit—Hospira) as a biosimilar to epoetin alfa (Epogen/Procrit—Amgen) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine for individuals with HIV.

FDA has approved epoetin alfa-epbx (Retacrit—Hospira) as a biosimilar to epoetin alfa (Epogen/Procrit—Amgen) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine for individuals with HIV. Epoetin alfa-epbx is also cleared for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. FDA's approval of epoetin alfa-epbx is based on a 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 that demonstrates epoetin alfa-epbx is biosimilar to epoetin alfa. The most frequent adverse effects of epoetin alfa-treated patients in clinical studies of the reference product included high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain, and chills. As with epoetin alfa, epoetin alfa-epbx must be dispensed with a patient Medication Guide that details the drug's uses and risks, and it carries a boxed warning to alert health care professionals and patients about increased risks of death, heart problems, stroke, and tumor growth and recurrence.