US FDA rejects Pfizer's Epogen biosimilar citing McPherson site warning
Pfizer announced that epoetin alfa had been rejected yesterday, explaining the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) related “to matters noted in a Warning Letter issued on February 14, 2017.”
The firm stressed that none of the problems detailed in the letter relate specifically to the production of epoetin alfa. It also pointed out that McPherson had been listed as the “potential manufacturing site” in the Biologics License Application (BLA).
In addition, Pfizer made clear the FDA had not asked for additional clinical data, which is something that was requested when the drug was rejected in 2015.
The FDA decision comes a month after its Oncologic Drugs Advisory Committee (ODAC) recommend the drug be approved.
Manufacturing problems
Pfizer’s drug is not the only product that has been negatively impacted by the warning letter.
In February, Momenta Pharmaceuticals inc said the warning letter was likely to delay the US FDA decision on a 40mg version of Glatopa – its generic of Teva’s MS drug Copaxone (glatiramer acetate injection) – which was also due to be produced at the McPherson.
Momenta said approval “may be dependent on the satisfactory resolution of the compliance observations stated in the FDA warning letter issued to Pfizer, the contracted fill/finish manufacturer for Glatopa" adding it "believes that an approval in the first quarter of 2017 is unlikely.”
As of June 23 the FDA has not made a decision regarding the 40mg version of Glatopa.
Pfizer gained the McPherson facility when it acquired Hospira in 2015. It is operated by the firm's contracting business, Pfizer CentreOne.
Remediation efforts
In May, John Young, president of Pfizer Essential Health, said the firm had started implementing corrective and preventive actions to address the issues identified by the FDA at McPherson.
He told analysts during Pfizer's Q1 call the firm is “making all the investments necessary to satisfy the items identified during the recent inspections, and our goal is to have these issues remediated in a timely fashion.”
