FDA Approves Biosimilar Pegfilgrastim-cbqv for Febrile Neutropenia

FDA

The FDA has approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv (Udenyca), which is a biosimilar of pegfilgrastim (Neulasta) that is given the day after chemotherapy to reduce the incidence of infection as manifested by febrile neutropenia.

Udenyca utilizes a prefilled syringe and autoinjector that allows for more choice and flexibility that can be individualized to meet the needs of patients and clinical practices. The decision to approve the biosimilar is based on findings from a comprehensive analytical data package and a study that evaluated pharmacokinetics, pharmacodynamics, and immunogenicity.

“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, chief of Medical Oncology and Hematology at the Renown Health William N. Pennington Cancer Institute, and professor of Clinical Medicine, University of Nevada, stated in a press release. “There are certain types of cancer patients, 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.”

The biosimilar is a leukocyte growth factor that is indicated to reduce the incidence of infection in those with non-myeloid cancers who are receiving myelosuppressive agents linked with a significance incidence of febrile neutropenia. The agent is also indicated to improve survival in those who are acutely exposed to myelosuppressive doses of radiation.

Notably, Udenyca cannot be used to mobilize peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Regarding safety, the adverse effects with at least a 5% difference in incidence compared with placebo are pain in the extremity and bone pain.

Reference

FDA approves Udenyca autoinjector. News release. Coherus BioSciences, Inc. March 6, 2023. Accessed March 6, 2023. https://investors.coherus.com/news-releases/news-release-details/fda-approves-udenycar-autoinjector