FDA Approves First New Biosimilar of 2020

On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved Pfizer’s NYVEPRIA (pegfilgrastim-apgf), a biosimilar of Amgen’s NEULASTA. NYVEPRIA is indicated to “decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.” According to a company press release, “The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.”

NYVEPRIA is the fourth biosimilar of NEULASTA to receive FDA licensure, following Mylan’s FULPHILA (pegfilgrastim-jmdb), Coherus’s FULPHILA (pegfilgrastim-jmdb), and Sandoz’s ZIEXTENZO (pegfilgrastim-bmez). These previously approved biosimilars were launched on the U.S. market over the course of 2018-2019. Pfizer’s press release, however, did not indicate a date for a U.S. launch. Over all, NYVEPRIA is the twenty-seventh biosimilar approved under the BPCIA regulatory regime, but it is the first biosimilar approval since the FDA approved Amgen’s AVSOLA (infliximab-axxq) on December 6, 2019.

NYVEPRIA is the subject of an ongoing BPCIA litigation that Amgen commenced against Pfizer and its affiliate Hospira earlier this year. A jury trial is scheduled for July 2022.