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FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia


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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 caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The biosimilar 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.

“It is important for patients to have access to safe, effective, and affordable biologic products, and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” said Leah Christl, PhD, Director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

The 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 demonstrate epoetin alfa-epbx is biosimilar to epoetin alfa. Epoetin alfa-epbx has been approved as a biosimilar, not as an interchangeable product.

Safety and Toxicity

The mostcommon side effects of epoetin alfa–treated patients in clinical studies of the reference product were hypertension, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection-site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection-site pain, and chills.

Epoetin alfa-epbx must be dispensed with a patient medication guide that provides information about the drug’s uses and risks. In addition, as with epoetin alfa, epoetin alfa-epbx contains a boxed warning to alert health-care professionals and patients about the increased risks of death, heart problems, stroke, and tumor growth or recurrence. Additional warnings include hypertension, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and, severe skin reactions.

For more information, visit FDA.gov. ■


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