The U.S. Food and Drug Administration has rejected Pfizer’s Biologics License Application (BLA) for its Epogen biosimilar over concerns about a manufacturing facility in McPherson, Kansas.
Pfizer said it received a complete response letter from the FDA that relates to matters noted in a warning letter from February concerning the McPherson facility. Pfizer said the issues noted in the warning letter did not relate specifically to the manufacture of epoetin alfa, but the company had listed this facility as the potential manufacturing site in the BLA.
Last month, the FDA’s Oncologic Drugs Advisory Committee recommended approval of the biosimilar across all indications.
Pfizer said the FDA has not asked for additional clinical data to support an approval.
“Pfizer submitted a corrective and preventative action plan to the FDA in March 2017, and has been diligently working to address the items outlined in the warning letter,” the comapn ysaid in a press release. “Pfizer provides regular updates to FDA on the status of its action plan, and remains dedicated to addressing all of FDA’s concerns with the McPherson, KS site.”