FDA Approves First Epoetin Alfa Biosimilar for Anemia Treatment

MAY 15, 2018
The FDA today 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, according to a press release issued by the agency. The drug 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 biological 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, in the press release. “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 demonstrates epoetin alfa-epbx is biosimilar to epoetin alfa. The FDA granted approval to Hospira for Retacrit as a biosimilar, not as an interchangeable product.

The most common adverse 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.

In addition, as with Epogen/Procrit, Retacrit contains a Boxed Warning to alert healthcare 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.


Reference

FDA approves first epoetin alfa biosimilar for the treatment of anemia [news release]: Silver Spring, MD; May 15, 2018. FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607703.htm. Accessed May 15, 2018.

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