FDA Rejects Pfizer's Epogen Biosim, Again

Jun 26, 2017

Endpoints News

Despite getting the green light from its in-house review and advisory committee, the FDA has rejected Pfizer's Epogen biosimilar.

Pfizer received a Complete Response Letter for the drug, a biosimilar to Amgen's blockbuster anemia med, which noted concerns about Pfizer’s manufacturing facility in McPherson, Kansas.

The agency had previously rejected the same drug in 2015 when Hospira submited the BLA, citing the need for more clinical data.

The potential manufacturing site in the recent BLA is a former Hospira fill-finish plant -- the same plant that led the FDA to reject a Momenta Copaxone generic in February of this year.

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