According to Pfizer, the letter is related to points made by the regulator in a February-issued warning letter after a routine inspection of the pharma’s McPherson facility in Kansas last year.
The facility was proposed as one of the manufacturing sites in the BLA by Pfizer for the proposed Epogen biosimilar.
Pfizer revealed that the issues raised by FDA in the warning letter are not related particularly to the manufacture of the biosimilar.
It also stated that the FDA did not request for any additional clinical data in the CRL to support an approval for the Epogen biosimilar.
In late May, an Oncologic Drugs Advisory Committee (ODAC) voted to recommend approval of the proposed biosimilar.
The committee’s recommendation as per Pfizer was on the briefing materials of FDA. In that, the FDA had come to a conclusion that the proposed biosimilar epoetin alfa has a lot of similarities to its reference candidates Epogen and Procrit (epoetin alfa).
The regulator also endorsed a demonstration that there are hardly any clinically meaningful differences between the proposed biosimilar and the references when it comes to the product’s safety, purity and potency.
Pfizer issued a statement which read: “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.
“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.”
The pharma giant added that it is committed to make the Epogen biosimilar available to patients and physicians as early as possible.