FDA Approves Nyvepria, a Biosimilar to Neulasta for Febrile Neutropenia

The Food and Drug Administration (FDA) on Thursday approved another biosimilar to Neulasta (pegfilgrastim), Nyvepria (pegfilgrastim-apgf) to decrease the incidence of infection due to febrile neutropenia in patients receiving myelosuppressive anti-cancer therapy.

“Chemotherapy-induced febrile neutropenia is a relatively common and severe side effect of some cancer treatments that could cause significant complications and can result in the alteration of treatment regimens,” Dr. Ali McBride, immediate past president of the Association of Community Cancer Centers, said in a press release issued by the biosimilar’s manufacturer. “The FDA approval of Nyvepria provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.”

A biosimilar is a biological product that is highly similar to an already-approved biological product, and that has no clinically meaningful differences in terms of safety, purity and potency from the reference product. The FDA requires biosimilars to meet the agency’s rigorous approval standards. Agency approval means “patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar,” according to the FDA website.

The agency based its decision on a review of data that demonstrated Nyvepria had a high degree of similarity to Neulasta.

The recommended dose of the biosimilar, according to its label, is 6 milligrams (mg) delivered by injection once per cycle of chemotherapy. Nyvepria should not be administered 14 days before and 24 hours after a patient receives chemotherapy. A weight-based dosing should be used in children who weigh less than 45 kilograms.

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

Check back later for what you need to know about this approval.