FDA Committee Recommends Approval of Epoetin Alfa Biosimilar Across All Indications


This is the first recommendation for a proposed erythropoiesis-stimulating agent biosimilar.

The FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of biosimilar epoetin alfa across all indications.

It is the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by an FDA advisory committee, according to a press release.

The favorable recommendation was based on a review of the totality of evidence, including a demonstration of comparable safety and efficacy for biosimilar epoetin alfa to its reference product, Procrit and Epogen, according to a press release.

“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,” Diem Nguyen, Global President, Americas, Pfizer Essential Health, said in a release. “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 US biosimilars portfolio.”

Pfizer is seeking FDA approval for the biosimilar for the treatment of anemia due to chronic kidney disease in patients on or not on dialysis; zidovudine in HIV-infected patients; the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy; and the reduction of allogenic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Before the FDA acts on the Biologics License Application for the proposed epoetin alfa biosimilar across all indications, it will take the ODAC’s recommendation into consideration, according to the release.

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