FDA Approves Pfizer Pegfilgrastim Biosimilar Nyvepria

The FDA has approved Pfizer’s pegfilgrastim biosimilar Nyvepria for use in lowering the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs.

There are 3 pegfilgrastim products already on the US market that also reference Amgen’s Neulasta. Those include Ziextenzo, Udenyca, and Fulphila.

Pfizer intends to launch Nyvepria on the US market later this year. No specific date was provided.

“The FDA approval of Nyvepria is a positive step that could both enable cost savings and increase access to an important treatment option,” said Andy Schmeltz, global president of Pfizer Oncology, in a statement.

“Chemotherapy-induced febrile neutropenia is a relatively common and severe [adverse] effect of some cancer treatments that could cause significant complications and can result in the alteration of treatment regimens,” said Ali McBride, PharmD, MS, BCPS, BCOP, immediate past president of the Association of Community Cancer Centers. “The FDA approval of Nyvepria provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.”

Pfizer now has 6 FDA-approved oncology biosimilars, 3 of which are indicated for supportive care for patients with cancer. Its total US-approved biosimilar portfolio, including the cancer agents, includes 9 biosimilars.

Pfizer's biosimilar engine has been active in the United States so far in 2020. The company brought a rituximab biosimilar (Ruxience) to market earlier this year, along with a trastuzumab (Trazimera).