Regulatory Affairs

FDA approves Pfizer’s epoetin alfa biosimilar Retacrit to treat anemia

PBR Staff Writer Published 16 May 2018

Pfizer’s Retacrit (epoetin alfa-epbx), a biosimilar to Amgen’s anemia drug Epogen/Procrit (epoetin alfa), has been approved by the US Food and Drug Administration (FDA) for all indications of the reference product.

Retacrit has been indicated for the treatment of anemia resulting from chronic kidney disease, chemotherapy, or use of zidovudine in HIV-infected patients.

The FDA has also approved Retacrit for treating anemia caused by decrease in red blood cell transfusions in patients undergoing elective, noncardiac or nonvascular surgery.

Retacrit is now the first and only approved biosimilar erythropoiesis-stimulating agent (ESA) in the US.

FDA center for drug evaluation and research therapeutic biologics and biosimilars staff director Leah Christl said: “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.

“Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

Retacrit’s approval was based on a review of evidence made up of structural and functional characterization, human pharmacokinetic and pharmacodynamic data, animal study data, clinical immunogenicity data and other clinical safety and effectiveness data.

The data proved Retacrit to have high degree of similarity with its reference product Epogen/Procrit.

Pfizer essential health US institutions president Berk Gurdogan said: “As the first approved epoetin alfa biosimilar in the U.S., 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 (RBC) transfusions in certain patients.

“We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community.”

Pfizer reached an agreement with Vifor Pharma for the commercialization of Retacrit in some selected channels.

In December 2017, Pfizer secured FDA approval for IXIFI (PF-06438179, infliximab-qbtx), its biosimilar to Johnson & Johnson’s rheumatoid arthritis drug Remicade (infliximab).

Image: Pfizer World Headquarters in Manhattan, New York pictured in 2016. Photo: courtesy of Coolcaesar/