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news.The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all indications.
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The committee has recommended the approval based on its assessment of the totality of evidence, comprising of showing comparable efficacy and safety of biosimilar epoetin alfa to its reference product Epogen and Procrit.
According to Pfizer, the FDA advisory committee for the first time has recommended the approval of biosimilar erythropoiesis-stimulating agent (ESA).
Pfizer is expecting FDA approval for four indications of the proposed biosimilar, including treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis and Zidovudine in HIV-infected patients.
The approval is also seeking to treat the effects of concomitant myelosuppressive chemotherapy, in addition to reducing allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac and nonvascular surgery.
The FDA will consider the committee’s recommendation before taking decisionon the Biologics License Application (BLA) for the proposed epoetin alfa biosimilar across all indications.
Pfizer has signed a deal with Vifor Pharma to commercialize the proposed epoetin alfa biosimilar in various channels.
Pfizer Essential Health Americas and global president Diem Nguyen said: “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.
“Following the approval and launch of Inflectra (infliximab-dyyb) in 2016, this positive recommendation – a first for a proposed ESA biosimilar – marks an important milestone for Pfizer’s U.S. biosimilars portfolio.”
Amgen’s Epogen is a prescription medicine that serves as the hormone erythropoietin to create more red blood cells, helping to raise the hemoglobin (Hb) level.
It will be used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions.
Image: Pfizer world headquarters in Manhattan, New York. Photo: courtesy of Coolcaesar.
