FDA Approves Epoetin Alfa-Epbx as a Biosimilar to Epogen/Procrit (Epoetin Alfa) for Anemia

Today, May 15th, 2018, the US Food and Drug Administration (FDA) approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or the use of zidovudine in patients with HIV infection. In addition, epoetin alfa-epbx has been approved for use before and after surgery in order to reduce the chance of needed red blood cell transfusions due to blood loss during surgery.

Epoetin alfa-epbx is a colony stimulating factor used to treat low blood cells, such as for conditions like anemia.

The FDA’s approval is based on a collection of reviewed evidence, such as 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 Epogen/Procrit. It is important to note that epoetin alfa-epbx has been approved as a biosimilar and not as an interchangeable product.

In clinical studies, common side effects of epoetin alfa-treated patients 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.

Epoetin alfa-epbx must be given with a patient Medication Guide that provides information about the drug’s uses and risks. Additionally, epoetin alfa-epbx includes a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, strokes, and tumor growth or recurrences. High blood pressure, seizures, and a condition in which the bone marrow stops making red blood cells are additional warnings as they can cause anemia, serious allergic reactions, and severe skin reactions.

Hospira Inc., a Pfizer company, was granted the FDA approval.

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