Pfizer’s biosimilar of Amgen’s epoetin alfa (Epogen/Procrit) has won backing in the US for approval across all proposed indications.
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended clearing the drug as a treatment for anaemia due to: chronic Kidney Disease (CKD), zidovudine in HIV-infected patients; and the effects of concomitant myelosuppressive chemotherapy.
The biosimilar should also be approved for reducing of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery, the Committee ruled.
The decision marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by a US FDA Advisory Committee, Pfizer noted.
“The Committee’s recommendation reinforces the potential value of biosimilars in expanding access to additional high-quality treatment options for the patients in the US who need them,” said Diem Nguyen, global president, Americas, Pfizer Essential Health.