The US Food and Drug Administration has approved Pfizer’s Retacrit, a biosimilar of Amgen's Epogen and Johnson & Johnson's Procrit.
Retacrit has been cleared for all indications cleared for its reference product, that is for treating anaemia due to chronic kidney disease (CKD), treatment with zidovudine in HIV-infected patients, and myelosuppressive chemotherapy.
The drug is also approved for the reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Retacrit is now the first and only biosimilar erythropoiesis-stimulating agent to be approved in the US, Pfizer noted.
As such, the drug “may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients,” said Berk Gurdogan, US Institutions President, Pfizer Essential Health.
“By providing potentially more affordable therapeutic options, biosimilar medicines can allow for the reallocation of resources to other areas of cancer care. This is positive news for the oncology community,” added George Rodgers, Professor of Medicine, Division of Hematology and Hematologic Malignancies, Department of Internal Medicine, University of Utah School of Medicine.
Retacrit is Pfizer’s third approved biosimilar in the US.