The US Food and Drug Administration (FDA) has approved United States-based Pfizer's Retacrit (epoetin alfa-epbx), a biosimilar to Amgen's anaemia drug Epogen/Procrit (epoetin alfa), for all indications of the reference product, it was reported yesterday.

The product has been indicated for the treatment of anaemia resulting from chronic kidney disease, chemotherapy, or use of zidovudine in HIV-infected patients. It is now the first and only approved biosimilar erythropoiesis-stimulating agent in the United States. The product approval was based on a review of evidence made up of structural and functional characterisation, human pharmacokinetic and pharmacodynamic data, animal study data, clinical immunogenicity data and other clinical safety and effectiveness data.

The US FDA has also approved the product for treating anaemia caused by decrease in red blood cell transfusions in patients undergoing elective, non-cardiac or nonvascular surgery.