The US Food and Drug Administration (FDA) has approved Pfizer’s Retacrit (epoetin alfa-epbx), a biosimilar to Amgen’s Epogen (epoetin alfa) and Johnson and Johnson’s Procrit/Eprex (epoetin alfa) for treating anemia. Epogen had 2017 global sales of $1.1 billion, and Procrit/Eprex had 2017 global sales of $972 million.

Pfizer’s Hospira filed an application with the FDA in December 2014 seeking approval of its biosimilar of Epogen. Reracrit is approved for treating anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

Pfizers’ biologics license application (BLA) for Retacrit was delayed when it received a Complete Response Letter (CRL) from the FDA in June 2017 regarding its BLA for its proposed epoetin alfa biosimilar over manufacturing issues. The CRL related to matters noted in a Warning Letter issued in February 2017 following a routine FDA inspection of the company’s facility in McPherson, Kansas in 2016. The facility was listed as the potential manufacturing site in the BLA for the proposed epoetin alfa biosimilar.

Source: FDA