FDA Approves Pegfilgrastim-apgf, Biosimilar to Pegfilgrastim

June 11, 2020

Pegfilgrastim-apgf 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.

The FDA has approved pegfilgrastim-apgf (Nyvepria), a biosimilar to pegfilgrastim (Neulasta), according to Pfizer, the developer of the agent.

Pegfilgrastim-apgf is now 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.

“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 (ACCC), said in a press release. “The FDA approval of (pegfilgrastim-apgf) provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.”

The approval was based on the review of a comprehensive data package and totality of evidence which demonstrated a high degree of similarity to the agent to its reference product.

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

“The FDA approval of (pegfilgrastim-apgf) is a positive step that could both enable cost savings and increase access to an important treatment option,” Andy Schmeltz, global president, Pfizer Oncology, said 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 (pegfilgrastim-apgf) available to US patients and physicians later this year.”

Notably, other pegfilgrastim biosimilars have also 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 non-myeloid 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 3-way pharmacokinetics and pharmacodynamics LA-EP06-104 trial. The study was designed to compare LA-EP2006 pegfilgrastim biosimilar with the US-sourced reference pegfilgrastim; the pegfilgrastim biosimilar with the European Union–sourced reference pegfilgrastim; and the US- with the EU-sourced reference pegfilgrastim. Results demonstrated that pharmacokinetics and pharmacodynamics similarity were observed in all 3 comparisons, and there were no clinically meaningful differences observed in safety and immunogenicity among the groups.

In addition, 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 over 300 patients.

References:

1. FDA APPROVES PFIZER’S ONCOLOGY SUPPORTIVE CARE BIOSIMILAR, NYVEPRIA™ (PEGFILGRASTIM-APGF) [news release]. New York. Published June 11, 2020. investors.pfizer.com/investor-news/press-release-details/2020/FDA-Approves-Pfizers-Oncology-Supportive-Care-Biosimilar-NYVEPRIA-pegfilgrastim-apgf/default.aspx. Accessed June 11, 2020.

2. FDA. Highlights of Prescribing information: NYVEPRIATM (pegfilgrastim-apgf) injection, for subcutaneous use. FDA website. Published June 2020. accessdata.fda.gov/drugsatfda_docs/label/2020/761111lbl.pdf. Accessed June 11, 2020.