Epoetin Hospira Highly Similar to Amgen’s Epogen/Procrit: FDA

FDA medical reviewers say the “totality of analytical data support the determination that Epoetin Hospira is highly similar to U.S.-licensed Epogen/Procrit notwithstanding minor differences in clinically inactive components.” That conclusion is included in a briefing document prepared for the 5/25 meeting of the Oncologic Drugs Advisory Committee that will consider Hospira’s BLA for the biosimilar of the Amgen reference product.

The document says Hospira wants its biosimilar to be licensed for the same four indications as Apogen/Procrit.

Medical reviewers say there are no clinically meaningful differences between Epoetin Hospira and Epogen/Procrit in terms of the safety, purity, and potency of the product. The committee members are asked to consider whether the totality of the evidence presented support licensure of Epoetin Hospira as an Epogen/Procrit biosimilar.