FDA Approves Epoetin Alfa Biosimilar for Anemia

The FDA has approved Pfizer’s biosimilar epoetin alfa-epbx (Retacrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The biosimilar is also approved for use before or after surgery to reduce the chance that red blood cell transfusions will be needed due of blood loss during surgery.

The approval of the biosimilar to epoetin alfa (Epogen) marks the first biosimilar approval of 2018 and the first biosimilar erythropoiesis-stimulating agent approved in the United States.

“As the first approved epoetin alfa biosimilar in the US, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell transfusions in certain patients,” said Berk Gurdogan, US Institutions president, Pfizer, in a statement.

The approval follows a comprehensive data package submitted by the pharmaceutical company demonstrating a high degree of similarity between epoetin alfa-apbx and its reference product. The evidence included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and efficacy data.

The FDA also noted the significance of the approval. “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 Cristl, PhD, director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research, in a statement. “Biosimilars can provide greater access to treatment options for patients, increasing competition, and potentially lower costs.”

In June last year, Pfizer received a Complete Response Letter from the FDA for the biosimilar based on concerns about the company’s manufacturing plant. The company noted that the Warning Letter did not relate specifically to the manufacture of epoetin alfa.