Pfizer Receives FDA Approval for Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta

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On June 11, Pfizer announced that the U.S. FDA had approved Nyvepria (pegfilgrastim-apgf) for the following indication: to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs (such as chemotherapy) associated with a clinically significant incidence of febrile neutropenia.

Nyvepria is a biosimilar of Amgen’s branded drug Neulasta, and Pfizer has announced plans to launch the product in the U.S. market later this year.

The FDA’s approval of Nyvepria was based on a review of a comprehensive data package and the totality of evidence demonstrating that Nyvepria is highly similar to its reference product, Neulasta. Nyvepria is currently also under review by the European Medicines Agency (EMA).

In the United States, Pfizer has had nine biosimilars approved, six of which are oncology biosimilars, while the remaining three are specifically approved for supportive care in cancer patients.

In July 2018, Pfizer’s Nivestym (filgrastim-aafi, filgrastim) also received FDA approval; it is a biosimilar to Amgen’s branded drug Neupogen.

To date, the FDA has approved four biosimilars of Neulasta and two biosimilars of Neupogen. Neupogen is a recombinant human granulocyte colony-stimulating factor (G-CSF); this medication is a “leukocyte-elevating” agent that increases white blood cell counts in patients. Neulasta is the long-acting formulation of Neupogen, with its metabolic half-life extended through polyethylene glycol (PEG) modification.

According to the performance report released by Amgen, Neulasta’s global sales in 2019 amounted to $3.221 billion ($2.814 billion in the U.S. market), representing a 28% decrease from the previous year; Neupogen’s global sales in 2019 totaled $264 million ($178 million in the U.S. market), also marking a 28% decline from the prior year.

Reference Source: FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA™ (pegfilgrastim-apgf)