Approved: First Biosimilar to Treat Anemia

Retacrit (epoetin alfa-epbx) approved as biosimilar to treat anemia

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to treat anemia.

This new approval is a biosimilar found under the name Retacrit (epoetin alfa-epbx). It's actually the first biosimilar of its kind to treat anemia.

According to the FDA, a biosimilar is a biological product that is highly similar to a biological product that has already been approved. The original product is known as a reference product. In this case, the reference product is Epogen/Procrit (epoetin alfa).

The FDA approved Retacrit to treat anemia that is caused by chemotherapy, chronic kidney disease or the use of zidovudine in patients with HIV. Anemia means the body has fewer red blood cells than normal and, as a result, the blood cannot carry enough oxygen to the rest of the body.

The FDA also approved this biosimilar to lessen the chance that patients will need blood transfusions because of blood loss during surgery. For this particular indication, epoetin alfa-epbx is to be given before and after surgery.

Epoetin alfa-epbx is available as an injection that can be administered into the vein or under the skin. Common side effects included high blood pressure, joint and muscle pain, fever, dizziness, cough, nausea and vomiting.

As with Epogen/Procrit, this new approval must be dispensed with a patient Medication Guide. This is because there is a risk of serious side effects. Retacrit also comes with a boxed warning because of a risk of death, heart problems, stroke, and tumor growth or recurrence. Your health care provider will determine whether this medication is right for you.

This new approval was granted to the Pfizer company Hospira Inc.