For just the tenth time since the implementation of the BPCIA, the FDA has approved a biosimilar product. Today, the FDA announced that it has approved Pfizer-subsidiary Hospira’s Retacrit™ (epoetin alfa-epbx) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit™ is the first FDA-approved biosimilar to Epogen®/Procrit®. According to the press release, “The FDA’s approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. Retacrit has been approved as a biosimilar, not as an interchangeable product.”
Hospira is currently engaged in district court patent litigation against Amgen regarding this biosimilar. This past September, a jury awarded Amgen $70 million in damages based on Hospira’s pre-approval manufacturing activities, which the jury found to infringe a now-expired patent. The judgment, however, is not yet final, as the verdict and damages award are the subject of pending post-trial motions.
UPDATE: The approved label for Retacrit™ is now available on the FDA website. In addition, Pfizer has published its own press release on this approval, stating: “RETACRIT is expected to be available in the U.S. at a significant discount to the current wholesaler acquisition cost (WAC) of Epogen and Procrit. WAC is not inclusive of discounts to payers, providers, distributors and other purchasing organizations.”