FDA Approves Pfizer’s Pegfilgrastim Biosimilar

The FDA has approved pegfilgrastim-apgf (Nyvepria), a biosimilar to pegfilgrastim (Neulasta), to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia, according to Pfizer, the manufacturer of the biosimilar.¹

The agency based its approval on comprehensive supportive evidence demonstrating that pegfilgrastim-apgf had a high degree of similarity to the reference product.

“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,” Ali McBride, PharmD, MS, BCPS, BCOP, immediate past president of the Association of Community Cancer Centers, stated in a press release. “The FDA approval of Nyvepria provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.”

According to its label,² the recommended dose of pegfilgrastim-apgf is 6 mg delivered subcutaneously once per chemotherapy cycle. The biosimilar should not be given in the period running from 14 days before and 24 hours after administration of chemotherapy. When used in pediatric patients who weigh less than 45 kg, weight-based dosing should be used.

The biosimilar is contraindicated in patients with a history of serious allergic reactions to G-CSF agents, including pegfilgrastim or pegfilgrastim products.

“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, Pfizer Oncology, stated in the press release. “We are proud to add this new, long-acting supportive care option to our robust portfolio, now with six FDA-approved oncology biosimilars including three specifically approved for supportive care for patients with cancer. We look forward to making Nyvepria available to US patients and physicians later this year.”

Other pegfilgrastim biosimilars have been previously approved by the FDA. In 2019, the FDA approved the pegfilgrastim biosimilar LA-EP2006 (pegfilgrastim-bmez; Ziextenzo) as a treatment to decrease the incidence of infection, exhibited from febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer therapy that is associated with a clinically significant incidence of febrile neutropenia.

The approval was based on analytical, preclinical, and clinical studies, including data from the pivotal three-way pharmacokinetics and pharmacodynamics LA-EP06-104 trial comparing LA-EP2006 pegfilgrastim biosimilar with US-sourced reference pegfilgrastim; the pegfilgrastim biosimilar with European Union–sourced reference pegfilgrastim; and US- with EU-sourced reference pegfilgrastim. Results showed that pharmacokinetics and pharmacodynamics similarity were demonstrated in all three comparisons, and there were no clinically meaningful differences observed in safety and immunogenicity among the groups.

In 2018, the FDA approved pegfilgrastim-cbqv (CHS-1701; Udenyca), a pegfilgrastim biosimilar, for patients with cancer receiving myelosuppressive chemotherapy. The approval was based on analytical similarity data between pegfilgrastim and the biosimilar, as well as pharmacokinetic, pharmacodynamic, and immunogenicity studies of more than 300 patients.

References

1. FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, Nyvepria™ (Pegfilgrastim-apgf). Posted June 11, 2020. https://bit.ly/2UzaN7E. Access June 11, 2020.
2. FDA Highlights of Prescribing Information for Nyvepria. Posted June 11, 2020. https://bit.ly/3cXclhL. Accessed June 11, 2020.