FDA Approves Pfizer's Epoetin Alfa Biosimilar, Retacrit

The FDA has approved Pfizer’s biosimilar epoetin alfa, referencing Epogen. The biosimilar, epoetin alfa-epbx, which will be marketed as Retacrit, is the first biosimilar approved in 2018, and the tenth biosimilar to be approved in the United States. The biosimilar is also approved in the European Union.

The FDA has approved the drug for the treatment of anemia caused by chronic kidney disease, chemotherapy, or the use of zidovudine in patients with HIV. The biosimilar is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be required because of blood loss.

Officials from the FDA noted the importance of today’s milestone 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 Christl, PhD, 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.”

A Pfizer representative told The Center for Biosimilars^® in an email that, while the launch timing for the drug will depend on a variety of factors, the company plans to launch Retacrit in 2018 at a “significant discount” to the wholesaler acquisition cost of the reference product.

Today’s approval is a notable win for Pfizer, which received a Complete Response Letter (CRL) for the drug in 2017 on the basis of agency concerns about the company’s manufacturing plant, despite an earlier recommendation of approval from the Oncologic Drugs Advisory Committee. While Pfizer received an FDA warning letter concerning the plant, the company underscored the fact that the issues did not pertain specifically to the epoetin alfa product, and no additional clinical data were requested in the CRL.

The approval comes on the heels of a CRL for another Pfizer product, a trastuzumab biosimilar, referencing Herceptin. For that biosimilar product, the FDA issued a CRL, announced on April 23, 2018, that cited the need for additional technical information, though no additional safety or clinical data were requested, said Pfizer.