Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar

Posted 10 August 2017 By Zachary Brennan

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The US Court of Appeals for the Federal Circuit on Thursday dismissed Amgen’s appeal related to a lawsuit over Pfizer’s Epogen (epoetin alfa) biosimilar.

But the win in court for Pfizer subsidiary Hospira does not mean that the biosimilar will launch in the US yet, as Pfizer reported on 22 June that it received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the application.

The CRL relates to issues from an FDA warning letter sent 14 February following a 2016 inspection of the company’s manufacturing facility in McPherson, Kansas.

The facility was listed as the potential manufacturing site in the Biologics License Application for the proposed epoetin alfa biosimilar. And although Pfizer said the issues noted in the letter “do not relate specifically to the manufacture of epoetin alfa,” FDA in the letter noted multiple complaints of cardboard contaminants in vials of vancomycin hydrochloride for injection.

And though the company recalled one lot associated with the particulates, FDA said, “you did not do so until more than four months after receiving the initial product complaint and determining that products in the lot had been contaminated with cardboard. Moreover, you received additional complaints about the same problem in the intervening time period but failed to take further action.”

Pfizer said it submitted a corrective and preventative action plan to FDA in March.

The CRL follows an FDA advisory committee’s vote 14-1 to support the approval of the Epogen biosimilar.

United States Court of Appeals for the Federal Circuit

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Categories: Biologics and biotechnology, Compliance, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: Epogen, epoetin alfa, complete response letter, Pfizer, Amgen

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