FDA Approves Epoetin Alfa Biosimilar

The FDA today granted approval to epoetin alfa-epbx (Retacrit) as a biosimilar—not an interchangeable drug—to epoetin alfa (Epogen/Procrit). The biosimilar was approved for the treatment of anemia caused by chronic kidney disease, chemotherapy, or with zidovudine treatment in patients with HIV, the FDA said in a press release.

Retacrit was also granted approval for use before and after surgery to reduce the need for red blood cell transfusions due to 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,” Leah Christl, PhD, director of the Therapeutic Biologics and Biosimilars Staff in the FDA Center for Drug Evaluation and Research, said in the release. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

The approval of Retacrit was based on a review that included comprehensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and efficacy data that demonstrated the biosimilarity of Retacrit to Epogen/Procrit, according to the FDA.

The most common adverse effects associated with treatment with epoetin alfa were high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain, and chills, the FDA said.

Additionally, Retacrit contains a Boxed Warning regarding increased risks of death, heart problems, stroke, and tumor growth or recurrence. Additional warnings from the FDA include high blood pressure, seizures, serious allergic reactions, severe skin reactions, and a condition in which bone marrow stops making red blood cells, causing anemia.