The FDA approved Nivestym, Pfizer’s biosimilar of Amgen’s Neupogen.
The agency said it based the approval on a comprehensive data package and the totality of evidence indicating a high degree of similarity between the biosimilar and the reference product.
Nivestym is indicated in the U.S. for decreasing the incidence of infection in patients with nonmyeloid malignancies receiving certain myelosuppressive anti-cancer drugs.
The approval marks the fourth Pfizer biosimilar approved by the FDA. The drug is expected to be sold at a significant discount to Neupogen’s current wholesale cost.