On November 13, Pfizer began marketing its biosimilar version of epoetin alfa. Pfizer launches Retacrit® at a 33.5% discount to Amgen’s reference product Epogen®. Retacrit was originally developed by Hospira, which Pfizer acquired in 2015. Retacrit was one of the first biosimilars approved in the EU. It had a long journey to reaching the market in … Continue reading Pfizer Launches Retacrit, First Biosimilar Version of Epogen and Procrit
Tag: Epogen
Pfizer Gets Green Light From the FDA on Epogen® Biosimilar
It has taken a long time, but Pfizer finally earned approval from the U.S. Food and Drug Administration (FDA) on the first biosimilar version of Epogen®. The drug, Retacrit® (epoetin alfa-epbx), had originally been submitted for approval in December 2014. Its much stalled road to approval is finally at an end. After an initial rejection, … Continue reading Pfizer Gets Green Light From the FDA on Epogen® Biosimilar
FDA Stuns With Rejection of Pfizer’s Retacrit
Following a 14-1 vote by its Oncology Drug Advisory Committee last month to recommend approval for Pfizer’s biosimilar version of Epogen®, the Food and Drug Administration (FDA) on June 22 sent the drug maker a complete response letter outlining its decision to reject the product.