Biosimilar Denied: Hospira's Retacrit Could Head Back To FDA In First Half 2016

28 Oct 2015

Breaking cone of silence around 351(k) applications with passed user fee dates, Hospira parent Pfizer says additional clinical trials not needed following complete response letter for epoetin alfa biosimilar.

FDA's complete response letter on Hospira Inc.'s biosimilar Retacrit shows the agency is not merely letting user fee goals under the 351(k) pathway pass it by.

Pfizer Inc., which completed its acquisition of Hospira in September, announced Oct. 27 that it received a complete response...