Silver Spring, MD—Today, the U.S. 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 use of zidovudine in patients with HIV infection. Retacrit has also been 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. The FDA granted approval of Retacrit to Hospira, Inc., a Pfizer company.
Biological 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 biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
The FDA’s approval of Retacrit 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 Retacrit is biosimilar to Epogen/Procrit. Retacrit has been approved as a biosimilar, not as an interchangeable product.
Like Epogen/Procrit, Retacrit must be dispensed with a patient medication guide that provides information about the drug’s uses and risks. In addition, as with Epogen/Procrit, Retacrit 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, an anemia-causing condition in which the bone marrow stops making red blood cells, serious allergic reactions and severe skin reactions.
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.
“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, Ph.D., 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.”