Udenyca® (pegfilgrastim-cbqv), a biosimilar to Neulasta, is now available in a single-dose prefilled autoinjector device.
Udenyca is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
The Food and Drug Administration approved the new autoinjector presentation in March 2023. The approval was based on a clinical study demonstrating pharmacokinetic and pharmacodynamic bioequivalence as well as comparable safety (including immunogenicity) of Udenyca administered with the autoinjector vs the prefilled syringe.
Udenyca is now available as a 6mg/0.6mL preservative-free solution in a single-dose prefilled autoinjector and in a single-dose prefilled syringe. The prefilled autoinjector is not suitable for use in pediatric patients weighing less than 45kg. It delivers the entire contents (6mg in 0.6mL) in a single injection and is not adjustable.
- Coherus announces US launch of Udenyca® News release. Coherus. Accessed May 22, 2023. https://www.globenewswire.com/news-release/2023/05/22/2673355/33333/en/Coherus-Announces-U-S-Launch-of-UDENYCA-Autoinjector.html.
- Udenyca. Package insert. Coherus; 2023. Accessed May 22, 2023. https://www.udenyca.com/hcp/wp-content/pdfs/udenyca-pi.pdf.