FDA, Manufacturing

The closest thing to a shoo-in Pfizer has ever handed to the FDA just got rejected

Pfizer $PFE had just about everything going for it when the regulators at the FDA undertook the final review of its biosimilar of Amgen’s blockbuster anemia med Epogen/Procrit. The in-house review at the agency bluntly said it was the same drug. All but one member of the FDA panel that reviewed it said it should get a green light. And then the Supreme Court axed Amgen’s legal challenge $AMGN on the 180-day notice rule, seemingly leaving the road to the drug market wide open.

Except for one thing.

The FDA had cited the manufacturing site in Kansas which Pfizer spotlighted in its application to make this copycat, and today it handed Pfizer a rejection. The CRL gives Amgen the delay it was fighting for in court, preserving a franchise that earned $1.3 billion last year – though that sum has been shrinking fast.

Pfizer says it’s already on it, looking to resolve the manufacturing issues outlined by the agency. And the pharma giant confirmed that there is no demand for additional data. Adds Pfizer:

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.

This is the second CRL for this biosimilar, developed by Hospira and bought up by the pharma giant as it decided to get into the knockoff business in a big way. The first arrived in late 2015, giving Pfizer plenty of time to get the followup application in order.

The rejection underscores again that no drug can be a 100% shoo-in for an approval, and it emphasizes just how vigilant the FDA can be on manufacturing concerns.

Image: Pfizer plant in McPherson, Kansas Google Maps

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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