FDA Approves Pfizer’s Epoetin Alfa Biosimilar

On May 15, 2018, FDA announced that it has granted Pfizer’s Hospira approval for Retacrit (epoetin alfa-epbx), a biosimilar to Amgen’s Epogen/Procrit (epoetin alfa), to treat anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in HIV patients. Amgen’s Epogen/Procrit made $1.1 million worldwide in 2017 sales.

According to FDA, approval of epoetin alfa-epbx is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates epoetin alfa-epbx is biosimilar to epoetin alfa.

Epoetin alfa-epbx, which is Pfizer’s third biosimilar approval in the United States, 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. The company reports that it has entered into an agreement with Vifor Pharma for the commercialization of epoetin alfa-epbx in certain channels.

In related news, Pfizer received a complete response letter (CRL) from FDA in April 2018 in response to the biologics license application for the company’s proposed trastuzumab biosimilar, which references Roche’s Herceptin (trastuzumab). Roche’s Herceptin made approximately CHF 7.01 billion (approximately US$7 billion) in 2017 sales. In the CRL, FDA emphasized the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application. Pfizer states it is working with FDA to address the contents of the letter.

Source: FDA,Pfizer