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Udenyca Onbody™, an on-body injector presentation of Udenyca® (pegfilgrastim-cbqv), has been made available by Coherus Biosciences.
Udenyca is a biosimilar to Neulasta (pegfilgrastim). It 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 approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
The approval of the on-body injector was supported by a comprehensive analytical and clinical data package as well as pharmacokinetic and pharmacodynamic bioequivalence data, which included an open-label, crossover study comparing the on-body injector to a prefilled syringe.
The on-body injector includes features such as a retractable needle mechanism, an indicator, status light and auditory signal to help patients confirm the dose has been administered. A health care provider must fill the on-body injector with Udenyca using only the co-packaged prefilled syringe. Approximately 27 hours after the on-body injector is applied to the patient’s skin (abdomen or back of arm), Udenyca will be delivered over approximately 5 minutes.
Following application of the on-body injector, patients should avoid activities such as traveling, driving, or operating heavy machinery for 26 to 29 hours. Use of the on-body injector has not been studied in pediatric patients and is not recommended for patients with hematopoietic subsyndrome of acute radiation syndrome.
Udenyca Onbody is supplied in a carton containing 1 on-body injector co-packaged with 1 prefilled syringe (6mg/0.6mL; contains additional solution and should not be used for manual SC injection). The device uses acrylic adhesive, which for patients with allergies to acrylics, may result in significant reaction.
Udenyca is available as a 6mg/0.6mL single-dose prefilled autoinjector and as a single-dose prefilled syringe.
References:
Coherus announces US launch of Udenyca Onbody™ a novel and proprietary state-of-the-art delivery system for pegfilgrastim-cbqv. News release. February 21, 2024. https://www.globenewswire.com/news-release/2024/02/21/2832750/33333/en/Coherus-Announces-U-S-Launch-of-UDENYCA-ONBODY-a-Novel-and-Proprietary-State-of-the-Art-Delivery-System-for-pegfilgrastim-cbqv.html.
