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Hospira's Epogen Biosimilar Appears Poised For Quick Advisory Cmte. OK

 
• By Derrick Gingery

US FDA will hold its first-ever half-day panel review for a biosimilar; Hopsira's epoetin, which references Amgen's Epogen, has no clinically meaningful differences despite clinical trial conduct issues and PK/PD uncertainty, agency concludes.

FDA entrance sign 2016

FDA may be taking another step toward its ideal biosimilar review and approval process with the advisory committee meeting for Hospira Inc.'s epoetin product.

The Oncologic Drugs Advisory Committee will only require about a half-day meeting (8 a.m. to 1:30 p.m.) to consider the proposed biosimilar of Amgen Inc

Hospira, now is part of Pfizer Inc

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