FDA Approves Biosimilar to Treat Chemotherapy-Related Anemia

The Food and Drug Administration (FDA) approved Retacrit (epoetin alfa-epbx), a biosimilar of Epogen/Procrit (epoetin alfa), to treat anemia caused by a number of factors — including undergoing chemotherapy – as well as chronic kidney disease or the use of zidovudine in patients who have HIV.

Retacrit is also approved to be used both before and after surgery to reduce the chance that a patient will need a red blood cell transfusion.

According to the American Cancer Society, common signs of anemia include fast heartbeat, shortness of breath, trouble breathing, dizziness, chest pain, swelling in the hands or feet, pale skin/nail beds and extreme fatigue.

Patients who are concerned that they might have anemia should seek out the care of their health care professional. And now, they may have a new agent to help.

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

Biological products, such as Epogen, are typically derived from a living organism. In order for a biosimilar to be approved, it must prove that it is very similar to the original biological product — called the reference product – and has no clinical or safety differences.

Retacrit’s approval is based on reviewed evidence of structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data.

Potential side effects of the drug include: 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 loss, white blood cell reduction, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills.