The US Food and Drug Administration (FDA) has approved Pfizer’s Retacrit (epoetin alfa-epbx), a biosimilar for Epogen and Procrit (epoetin alfa), for the treatment of anaemia.
Retacrit is the first erythropoiesis-stimulating agent (ESA) biosimilar approved in the US.
The drug is indicated for anaemia caused by chronic kidney disease, chemotherapy or the use of zidovudine drug in HIV patients.
It is also approved for use before and after surgery to minimise the risk of red blood cell transfusions due to blood loss during elective, non-cardiac, non-vascular surgery.
Pfizer Essential Health US institutions president Berk Gurdogan said: “As the first approved epoetin alfa biosimilar in the US, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anaemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients.”
The FDA approval comes after the review of a comprehensive data package submitted by Pfizer indicating high similarity between Retacrit and its reference products, Epogen and Procrit.
This data was obtained from structural and functional characterisation, animal studies, analysis of human pharmacokinetics and pharmacodynamics, clinical immunogenicity, safety and effectiveness.
Pfizer has already signed an agreement with Vifor Pharma for the commercialisation of the biosimilar in select channels across the US.
Previously, the company secured FDA approval for two other biosimilars. Its pipeline currently contains 11 different biosimilar molecules with six in mid-to-late stage clinical development.