FDA approves pegfilgrastim biosimilar Udenyca OnBody autoinjector

Biosimilars/News | Posted 06/02/2024 post-comment0 Post your comment

On 26 December 2023, Coherus BioSciences announced the US Food and Drug Administration’s (FDA) approval of Udenyca OnBody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

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Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy [1]. The originator product is Amgen’s Neulasta. Udenyca was first approved in the US in 2018 [2] and Coherus’ Auto-injector version was approved in early 2023 [3]. 

Now, Udenyca OnBody is worn directly on the patient’s body and injects Udenyca into the patient. After the drug is administered, the needle automatically retracts, which, can reduce the risk of injury from the needle. The device also has an indicator and status light, as well as an auditory signal that helps patients confirm that Udenyca has been administered. 

‘We expect that Udenyca Onbody’s 5-minute injection time and innovative retractable needle mechanism will be well received by cancer patients, their caregivers and doctors,’ said Paul Reider, Coherus’ chief commercial officer.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 6]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 6]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
3. GaBI Online - Generics and Biosimilars Initiative. US and EC approvals for Hyrimoz, US approval for Udenyca autoinjector [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 6]. Available from: www.gabionline.net/biosimilars/news/us-and-ec-approvals-for-hyrimoz-us-approval-for-udenyca-autoinjector

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