FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia

On May 15, 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. Epoetin alfa-epbx 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.”

Biologic products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms, or yeast. A biosimilar is a biologic product that is approved based on data showing that it is highly similar to a biologic product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity, and potency (ie, safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

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

The most common side effects of epoetin alfa–treated patients in clinical studies of the reference product were high blood pressure; 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.

Like epoetin alfa, 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 increased risks of death, heart problems, stroke, and tumor growth or recurrence. Additional warnings include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions, and severe skin reactions.

The FDA granted approval of epoetin alfa-epbx to Hospira Inc, a Pfizer company.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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