FDA Approves 'Biosimilar' Drug to Treat Certain Types of Anemia
TUESDAY, May 15, 2018 -- Retacrit (epoetin alfa-epbx) has been approved by the U.S. Food and Drug Administration as the first "biosimilar" to the anemia drugs Epogen and Procrit.
Epogen and Procrit are approved to treat anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.
Previously noted side effects of epoetin alfa include high blood pressure, joint pain, muscle spasm, fever, dizziness, blood vessel blockage, and respiratory infection, the FDA said. As with Epogen/Procrit, Retacrit's label includes a boxed warning about increased risk of death, heart problems, stroke, tumor growth, high blood pressure, seizures, and serious allergic 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," Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDA's Center for Drug Evaluation and Research, said in a statement. "Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs."
Retacrit is produced by Hospira Inc., a unit of New York City-based Pfizer.
Posted: May 2018