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FDA Rejects Pfizer's Anemia Drug Biosimilar



The pharmaceutical company’s Biologics License Application (BLA) for epoetin alpha has been rejected by the regulator.

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June 27, 2017 | by Sarah Hand, M.Sc.

Pfizer announced that they have received a Complete Response Letter (CRL) from the FDA regarding its biosimilar version of Amgen’s anemia drug Epogen. The pharmaceutical company’s Biologics License Application (BLA) for epoetin alpha has been rejected by the regulator.

According to a press release issued by Pfizer, the CRL references a warning letter sent to Pfizer subsidiary Hospira in February over manufacturing issues at its pharmaceutical manufacturing facility in McPherson, Kansas. While the noted violations did not directly relate to the manufacture of the epoetin alfa biosimilar, Pfizer had listed the plant as a potential future production site for the biologic.

The FDA did not ask Pfizer for more clinical data, making it unclear what the pharmaceutical company needs to do next. In May, an FDA advisory panel recommended that Pfizer’s biosimilar be approved for all indications of its reference biologic.

Pfizer acquired Hospira in 2015, and with it came a number of pharmaceutical manufacturing facilities. Despite the setback, the Pfizer release maintains that the company is working towards making this biosimilar available as soon as possible.

“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,” said a Pfizer spokesperson in a recent 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.”

Both Amgen and Johnson & Johnson sell branded versions of epoetin alfa, which are marketed as Epogen and Procrit, respectively. The biologic drug is used to treat patients with anemia caused by chronic kidney disease.

Keywords:  FDA, Biosimilar, Biologic


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