FDA Denies Pfizer’s Epogen Biosimilar… Again

The FDA has rejected Pfizer’s answer to Amgen’s blockbuster Epogen for the second time over fill-finish plant concerns.

Pfizer Sign / Image: FiercePharma
Pfizer Sign / Image: FiercePharma

A recent FiercePharma article noted that the FDA issued a complete response letter (CRL) to Pfizer rejecting their biosimilar for Amgen’s Epogen. The prescription medicine acts as the hormone erythropoietin to help boost the body’s ability to create red blood cells and raise hemoglobin levels for dialysis patients. Just a month ago, the FDA and an advisory committee gave a glowing endorsement to the biosimilar only to deny approval last Thursday.

The drug was rejected for the first time in 2015, but the FDA didn’t ask for additional clinical data supporting further approval. The CRL noted issues within Pfizer’s fill-finish plant, the same plant that contributed to the FDA’s denial of their Copaxone equivalent. The plant issues were defined in a warning letter that pinned Pfizer for repeated failings throughout the Hospira manufacturing network, which Pfizer bought in 2015 for $15 billion.

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