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

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 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...