The U.S. Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) recommended approval of Pfizer’s proposed epoetin alfa biosimilar across all indications. This marks the first time a biosimilar erythropoiesis-stimulating agent has been recommended for approval by a U.S. FDA Advisory Committee.
The committee’s favorable recommendation was based on its review of the evidence, including demonstration of comparable efficacy and safety of biosimilar epoetin alfa to its reference product, Epogen and Procrit (epoetin alfa).
The company is seeking FDA approval to treat anemia due to chronic kidney disease in patients on dialysis and not on dialysis, Zidovudine treatment in HIV-infected patients, and the effects of concomitant myelosuppressive chemotherapy.
Pfizer is also seeking an indication to treat the reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
The FDA will take the committee’s recommendation into consideration before taking action on the Biologics License Application (BLA) for the proposed epoetin alfa biosimilar across all indications.
“The committee’s recommendation reinforces the potential value of biosimilars in expanding access to additional high-quality treatment options for the patients in the U.S. who need them,” said Diem Nguyen, global president, Americas, Pfizer Essential Health.
Pfizer has entered into an agreement with Vifor Pharma Inc. for the commercialization of its proposed epoetin alfa biosimilar in certain channels.