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Pfizer Excludes EU Biosimilar Experience From US Epoetin Application

 
• By Derrick Gingery

Even though US product has same cell line and drug product formulation as EU-approved Retacrit, Hospira subsidiary did not bridge to it in its US biosimilar application, meaning US FDA could not consider EU safety and efficacy experience.

Bridge

FDA will complete its review of Pfizer Inc.'s proposed epoetin biosimilar without considering nearly a decade's worth of experience with the product in Europe, even though it is available and the company acknowledged the product is heavily related to its EU-approved counterpart.

Agency reviewers do not have access to data on the European-approved version of the company's proposed biosimilar of Amgen Inc.'s Epogen/Procrit (epoetin alfa) because Pfizer's subsidiary Hospira Inc

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