FDA Gives First-Time Approval for Epoetin Alfa Biosimilar for Anemia Treatment

The FDA approved Retacrit (epoetin alfa-epbx), marking the first time a biosimilar to Epogen/Procrit (epoetin alfa) has been approved for treatment of anemia.

The medication is approved to treat anemia caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with HIV infection. It also approved for use before and after surgery to reduce the possibility of red blood cell transfusions being needed due to blood loss during surgery.

The agency’s approval was based on a review of clinical safety and effectiveness data that showed biosimilarity, including extensive structural and functional characterization and pharmacoequivalence data.