FDA Approves New Biosimilar for Anemia

The US Food and Drug Administration has approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or zidovudine treatment for human immunodeficiency virus infection.

Retacrit is also approved for use before and after surgery to reduce the potential need for blood transfusions due to blood loss during surgery.

The first approved biosimilar to epoetin alfa, Retacrit was granted approval following an evidence review of its extensive structural and functional characterization, as well as animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other data that demonstrates the biosimilarity of Retacrit to epoetin-alfa.

Common reported side effects with epoetin-alfa use include high blood pressure, joint pain, muscle spasm, fever, dizziness, and medical device malfunction, among others.

“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, Ph.D., 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.”

—Christina Vogt

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