FDA nixes Pfizer’s Epogen biosimilar and requests a fix

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For the second time in 2017, Pfizer has received a disappointing letter about its progress toward FDA approval for a biosimilar product similar to the drug Epogen. The root of the problem lies with manufacturing facilities that may produce the biosimilar, not with the safety or biosimilarity to Epogen, Pfizer notes.

In February 2017 Pfizer received a letter from the FDA that warned about particulate matter (cardboard) in some batches of other drugs manufactured in its facility in McPherson, KS, in 2016. The company responded by taking steps to address the concerns.

On May 25, Pfizer received good news: the

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