By PPN News Staff
The FDA approved epoetin alfa-epbx (Retacrit, Pfizer) as a biosimilar to Epogen/Procrit (epoetin alfa (Epogen/Procrit, Amgen) to treat anemia caused by chronic kidney disease, chemotherapy or use of zidovudine in patients with HIV infection. Epoetin alfa-epbx is approved as a biosimilar, not an interchangeable product.
Epoetin alfa-epbx also is 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.
Generally, biological products are 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 (reference product) 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 demonstrate Retacrit is biosimilar to Epogen/Procrit.
The most common side effects in patients receiving epoetin alfa 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.
Similar to the reference product, epoetin alfa-epbx must be dispensed with a patient Medication Guide that provides information about the drug’s uses and risks, and that contains a boxed warning to alert health care professionals and patients about increased risks for 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.
“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, the 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.”
For full prescribing information, click here.
Epoetin alfa-epbx is expected to be available in the U.S. at a significant discount to the current wholesaler acquisition cost (WAC) of Epogen and Procrit. WAC does not reflect discounts to payers, providers, distributors and other purchasing organizations.
Pfizer has entered into an agreement with Vifor Pharma Inc. for the commercialization of RETACRIT in certain channels.