Pfizer gets another CRL for biosimilar Retacrit

Pfizer Inc. (NYSE:PFE) said it received a second complete response letter from FDA for a BLA for Retacrit epoetin alfa. The candidate is a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ).

The pharma said the CRL relates to a February warning letter regarding a facility in Kansas that was listed as a manufacturing site in the BLA. However, the concerns in the warning letter do not relate specifically to the biosimilar's manufacturing, Pfizer said...