Patients with anemia caused by chronic kidney disease, chemotherapy, or those with HIV who take Retrovir (zidovudine) will soon have a new medication option in the form of Retacrit (epoetin alfa-epbx). The drug is the first biosimilar for epoetin-alfa to gain US Food and Drug Administration (FDA) approval as an anemia treatment. Retacrit is also used before and after surgery to minimize the chance patients will need red blood cell transfusions as a result of blood loss during their procedure.
Approval for Retacrit as a biosimilar to Epogen/Procrit was granted to the Pfizer company Hospira Inc. To qualify as a biosimilar, drug manufacturers need to provide the FDA with data demonstrating the product is “highly similar” to a reference biological product which has already gained FDA approval. Furthermore, manufacturers must also demonstrate it has no clinically meaningful differences in safety and effectiveness from the reference product.
Leah Christl, PhD, director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research, commented: “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”
Biological products may come from a variety of living organisms, including humans, animals, microorganisms, and yeast. Approval of Retacrit was granted following a review of the evidence, which demonstrated that the product is indeed a biosimilar to Epogen/Procrit.
The drug will be dispensed with a patient Medication Guide providing information on the use of the drug and associated risks. It also contains a Boxed Warning to alert healthcare professionals and patients about the increased risks of death, heart problems, stroke, and growth or reoccurrence of tumors.
Common Side Effects of Retacrit
A variety of side effects were reported during clinical studies of the reference product (Epogen/Procrit), including: 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.
More About Biosimilars
In May 2018, FDA Commissioner Scott Gottlieb, MD, announced that the agency would be taking steps to implement a Biosimilar Action Plan to ease the approval process and route to market for biosimilar products. The availability of a greater variety of biosimilar products could result in cheaper medication for patients and increased price competition in the marketplace, he suggested.
Retacrit was approved as a biosimilar, not an interchangeable product. To be categorized as an interchangeable product, drugs need to meet additional requirements and go through further testing and evaluation. An interchangeable product is expected to produce the same clinical result as a reference product and is data evaluating the safety and efficacy implications of alternating or switching between the two products.
Currently, there are no interchangeable biosimilar approvals in the United States, but this looks likely to change in the coming years, as a number of pharmaceutical companies have already submitted applications to the FDA.
For full prescribing information on Retacrit visit: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf
