FDA Approves First Epoetin Alfa Biosimilar for Anemia Treatment – APhA submits compounding comments to FDA. – (866) 348-2889.
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.