FDA Approves Single-Dose Autoinjector of Biosimilar Pegfilgrastim-cbqv for Febrile Neutropenia

The FDA has approved a prefilled syringe and autoinjector of the biosimilar pegfilgrastim-cbqv (Udenyca) for patients undergoing myelosuppressive chemotherapy. The single-dose of the biosimilar allows for at-home or in-office administration the day after chemotherapy offering more choice and flexibility to meet the needs of patients and clinical practices.¹

Udenyca is a biosimilar of the leukocyte growth factor pegfilgrastim (Neulasta), indicated to reduce the incidence of infection in those with nonmyeloid cancers who are receiving myelosuppressive agents linked with a significance incidence of febrile neutropenia and Increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Findings from a comprehensive analytical data package and a study that evaluated pharmacokinetics, pharmacodynamics, and immunogenicity, support the decision according to a news release from the developer Coherus BioSciences Inc.¹

The autoinjector is triggered by push-on-skin activation and commercial availability of the agent is planned for the second quarter of 2023.¹ The single-dose prefilled autoinjector contains 6 mg of pegfilgrastim-cbqv, a clear, colorless, preservative-free solution. Of note, the needle cap is not made with natural rubber latex. Each dispensing pack containing one 6 mg/0.6 mL prefilled autoinjector.²

Prescribing information indicated that the autoinjector is not suitable for use in pediatric patients weighing less than 45 kg as the dose is not adjustable.²

“The introduction of the autoinjector option for Udenyca, with the ability to be administered at home or in the doctor’s office, will provide increased choice and control for patients and physicians, ultimately making treatment more accessible to patients,” said Lee Schwartzberg, MD, in a news release.¹ “There are certain types of patients [with cancer], those who live far away, have an active lifestyle, or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device.” Schwartzberg is chief of medical oncology and hematology at the Renown Health William N. Pennington Cancer Institute, and professor of clinical medicine, University of Nevada in Reno.

Udenyca is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.^1,2

Regarding safety, the adverse effects with at least a 5% difference in incidence compared with placebo are pain in the extremity and bone pain. Udenyca comes with warnings for fatal splenic rupture, acute respiratory distress, serious allergic reactions, including anaphylaxis, sickle cell crises, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential for tumor growth stimulatory effects on malignant cells, development of myelodysplastic syndrome and acute myeloid leukemia in patients with breast and lung cancer, aortitis, and increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes.^1,2

References

1. FDA approves Udenyca autoinjector. News release. Coherus BioSciences Inc. March 6, 2023. Accessed March 7, 2023. https://investors.coherus.com/news-releases/
2. Udenyca. Prescribing information. Coherus BioSciences Inc; 2023. https://udenyca.com/hcp/wp-content/pdfs/