Pfizer Launches RETACRIT (Epoetin Alfa-epbx) Biosimilar in United States

Following the FDA’s approval of Retacrit® (epotein alfa-epbx) as the first U.S. biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® this past May, today Pfizer announced that it has launched Retacrit® in the United States.  According to reports, Pfizer began shipping Retacrit® to wholesalers on November 12, 2018, at a wholesale acquisition cost (WAC) representing a 57% discount compared to Procrit® and a 33.5% discount compared to Epogen®.

This is Pfizer’s third biosimilar launch in the United States and its second in just the past 6 weeks. Previously, Pfizer launched Inflectra® (infliximab-dyyb) in November 2016, and Nivestym® (filgrastim-aafi) early last month.  Retacrit® is the sixth biosimilar to launch in the United States, and the third in 2018 alone.

Pfizer-subsidiary Hospira remains engaged in patent litigation against Amgen regarding the development of Retacrit®.  This past September, a federal district court in Delaware entered final judgment against Hospira, awarding Amgen approximately $80 million, after a jury found that Hospira infringed a now-expired Amgen process patent by manufacturing fourteen batches of drug substance in 2013-2015.  The case is currently on appeal before the Federal Circuit.