Pfizer’s Biosimilar to Epogen Nears Final FDA Approval

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The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee in a 14–1 vote recommended approval of a Pfizer drug that is a biosimilar compound to epoetin alfa (Amgen’s brand name anemia drug Epogen). The committee voted to support the biosimilar drug for approval of all four of Epogen’s clinical indications, making it the first biosimilar of an erythropoiesis-stimulating agent in the US recommended for approval by an FDA advisory committee.

Analytical similarity data between the biosimilar and the FDA-licensed reference product is the basis for biosimilar development. The new biosimilar product must be demonstrated to be